INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

Summary

The FDA issued a Class I for INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273 by Boston Scientific Corporation. Reason: The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e.

Details

Product Description

INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

Lot/Code Info: a) V272, Serial Numbers: 100002, 100014, 100017, 100021, 100028, 100037, 100048, 100052, 100053, 100054, 100065, 100067, 100068, 100075, 100077, 100080, 100092, 100093, 100096, 100097, 100098, 100099, 100101, 100104, 100106, 100107, 100108, 100114, 100116, 100118, 100119, 100120, 100124, 100127, 100136, 100152, 100153, 100155, 100159, 100161, 100162, 100165, 100168, 100170, 100171, 100173, 100175, 100176, 100179, 100194, 100195, 100199, 100201, 100202, 100203, 100205, 100206, 100211, 100212, 100216, 100218, 100219, 100221, 100224, 100226, 100227, 100228, 100230, 100232, 100233, 100237, 100238, 100240, 100241, 100242, 100245, 100247, 100249, 100250, 100253, 100256, 100257, 100258, 100261, 100266, 100270, 100272, 100276, 100277, 100280, 100281, 100287, 100289, 100290, 604977, 604982, 604984, 604986, 604987, 604988, 604991, 604992, 604998, 604999, 605002, 605003, 605004, 605005, 605006, 605007, 605009, 605010, 605011, 605013, 605014, 605015, 605017, 605020, 605021, 605022, 605023, 605025, 605026, 605027, 605028, 605029, 605035, 605036, 605037, 605039, 605041, 605047, 605049, 605051, 605052, 605055, 605057, 605058, 605061, 605062, 605063, 605064, 605065, 605070, 605073, 605075, 605076, 605079, 605080, 605082, 605085, 605087, 605088, 605090, 605096, 605098, 605099, 605100, 605103, 605108, 605112, 605115, 605117, 605118, 605120, 605124, 605127, 605128, 605129, 605133, 605135, 605136, 605137, 605140, 605141, 605147, 605149, 605150, 605151, 605152, 605153, 605154, 605155, 605158, 605159, 605161, 605162, 605163, 605164, 605166, 605168, 605170, 605172, 605173, 605174, 605175, b) V273, Serial Numbers: 100001, 100002, 100006, 100007, 100013, 100014, 100015, 100017, 100019, 100030, 100032, 100033, 100034, 100035, 100036, 100037, 100038, 100042, 100044, 100045, 100046, 100047, 100048, 100049, 100054, 100056, 100057, 100058, 100060, 100062, 100066, 100067, 100069, 100071, 100072, 100076, 100083, 100084, 100086, 100087, 100088, 100089, 100090, 100091, 100093, 100096, 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101258, 101259, 101260, 101261, 101262, 101263, 101265, 101271, 101273, 101274, 101275, 101277, 101278, 101279, 101280, 101282, 101286, 101287, 101288, 101290, 101292, 101293, 101295, 101297, 101300, 101303, 101304, 101306, 101311, 101312, 101313, 101314, 101315, 101318, 101319, 101323, 101324, 101325, 101327, 101329, 101330, 101332, 101333, 101334, 101337, 101338, 101340, 101341, 101342, 101343, 101345, 101346, 101347, 101350, 101351, 101353, 101354, 101355, 101356, 101357, 101359, 101360, 101362, 101364, 101369, 101370, 101372, 101373, 101374, 101375, 101377, 101379, 101380, 101383, 101384, 101385, 101386, 101387, 101389, 101390, 101391, 101392, 101393, 101397, 101400, 101401, 101402, 101403, 101404, 101407, 101408, 101409, 101410, 101411, 101412, 101413, 101414, 101415, 101417, 101418, 101419, 101420, 117819, 117820, 117822, 117824, 117825, 117826, 117831, 117833, 117836, 117838, 117839, 117842, 117844, 117846, 117847, 117848, 117851, 117852, 117854, 117855, 117856, 117857, 117860, 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118041, 118046, 118047, 118049, 118051, 118052, 118054, 118055, 118056, 118057, 118058, 118059, 118062, 118063, 118066, 118068, 118069, 118070, 118072, 118074, 118075, 118076, 118077, 118078, 118081, 118084, 118085, 118087, 118088, 118091, 118094, 118095, 118096, 118098, 118101, 118104, 118105, 118106, 118108, 118109, 118110, 118111, 118113, 118114, 118115, 118116, 118118, 118119, 118120, 118121, 118122, 118123, 118124, 118125, 118127, 118129, 118130, 118131, 118133, 118134, 118135, 118136, 118138, 118141, 118143, 118145, 118147, 118148, 118149, 118150, 118152, 118153, 118154, 118155, 118156, 118158, 118159, 118163, 118164, 118167, 118168, 118169, 118170, 118173, 118174, 118175, 118176, 118177, 118178, 118179, 118181, 118182, 118185, 118186, 118187, 118188, 118189, 118190, 118191, 118192, 118193, 118194, 118195, 118197, 118198, 118199, 118200, 118201, 118203, 118206, 118208, 118211, 118212, 118213, 118217, 118218, 118219, 118223, 118224, 118225, 118226, 118227, 118228, 118229, 118231, 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118880, 118882, 118883, 118884, 118885, 118886, 118887, 118888, 118891, 118894, 118895, 118896, 118897, 118898, 118899, 118900, 118901, 118902, 118903, 118907, 118908, 118909, 118910, 118912, 118914, 118918, 118919, 118920, 118921, 118922, 118923, 118924, 118928, 118929, 118933, 118935, 118936, 118937, 118938, 118939, 118942, 118944, 118945, 118946, 118947, 118949, 118950, 118951, 118954, 118955, 118957, 118958, 118959, 118961, 118962, 118967, 118968, 118972, 118974, 118977, 118978, 118979, 118980, 118981, 118982, 117901, 118894 c) W273, Serial Numbers: 100003, 100005, 100009, 100024, 100030, 100037, 100091, 100092, 100093, 100100, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100126, 100021, 100118, 100121, 100127

Quantity Affected: 1707 units

Reason for Recall

The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population

Type: Voluntary: Firm initiated

Recall Initiated: 2021-06-03

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