BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number V173 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959); Data Problem (3196)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2022 |
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) had reached elective replacement indicator (eri) and rv output was programmed to auto 5v.The health care professional (hcp) was inquired whether eri had turned on rvat as they had thought rvat was programmed off.Technical services (ts) explained that eri does not turn on rvat, which indicates that rvat was programmed on prior to eri.A request was made to have data from this crt-p analyzed.Data analysis confirmed the battery appeared to be depleting normally, however the crt-p experienced a power on reset (por) consistent with the high impedance battery condition.Device replacement was recommended.Additional information received reported that this crt-p entered safety mode and was explanted/replaced.No additional adverse patient effects were reported.This crt-p will be returned for analysis.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had reached elective replacement indicator (eri) and rv output was programmed to auto 5v.The health care professional (hcp) was inquired whether eri had turned on rvat as they had thought rvat was programmed off.Technical services (ts) explained that eri does not turn on rvat, which indicates that rvat was programmed on prior to eri.A request was made to have data from this crt-p analyzed.Data analysis confirmed the battery appeared to be depleting normally, however the crt-p experienced a power on reset (por) consistent with the high impedance battery condition.Device replacement was recommended.Additional information received reported that this crt-p entered safety mode and was explanted/replaced.No additional adverse patient effects were reported.This crt-p will be returned for analysis.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode due to system resets.It was confirmed that brady therapy remained available.The system resets caused the device to enter safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
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Search Alerts/Recalls
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