Model Number V173 |
Device Problems
Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)
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Patient Problems
No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) reached explant indicator and then went down to end of life (eol) so quickly.The field representative requested for an analysis.The device 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) reached explant indicator and then went down to end of life (eol) so quickly.The field representative requested for an analysis.The device was explanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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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.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 related to telemetry attempts 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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