BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number V172 |
Device Problems
Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Syncope (1610); No Code Available (3191); Syncope/Fainting (4411)
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Event Date 01/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This device was not returned as our records indicate it was retained by the explanting hospital.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode, and the associated codes were 0x40, 0x0, 0x0.The patient presented to the emergency room (er) due to syncope.Additional information received indicated that this crt-p exhibited oversensing and pacing inhibition with greater than two seconds of asystole.This crt-p was explanted.No additional adverse patient effects were reported.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode, and the associated codes were 0x40, 0x0, 0x0.The patient presented to the emergency room (er) due to syncope.Additional information received indicated that this crt-p exhibited oversensing and pacing inhibition with greater than two seconds of asystole.This crt-p was explanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This device was not returned as our records indicate it was retained by the explanting hospital.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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