BOSTON SCIENTIFIC CORPORATION INTUA; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number V273 |
Device Problems
Premature Discharge of Battery (1057); High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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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) and left ventricular (lv) lead exhibited high out-of-range pace impedance measurements greater than 2,000 ohms.In addition, the crt-p had entered safety mode and its battery was suspected to be depleting prematurely.This crt-p was explanted and replaced, and the lv lead was surgically abandoned.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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