Model Number G158 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586)
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Patient Problem
Electric Shock (2554)
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Event Date 05/10/2022 |
Event Type
Injury
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Manufacturer Narrative
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If the product is returned, analysis would be performed and this report would be updated at that time.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded code 1007, message indicator that the shocking capacitors are not charged to the programmed voltage 45 seconds after the start of charging.Reportedly, the patient was received at the emergency room due to multiple shocks of atrial fibrillation with rapid ventricular response that exhausted the therapy.Technical services reviewed the case and indicated the issue could be related to an open circuit condition on the right ventricular (rv) lead.It was recommended to replace immediately this crt-d and the rv lead if the open circuit is confirmed.Subsequently, this crt-d was explanted, replaced and it is not expected to be returned for analysis.Reportedly, the shorted lead condition was discarded after the device data was remotely analyzed by engineering.The rv lead was working adequately.It appears that the device lost the ability to charge due to some other cause.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If the product is returned, analysis would be performed and this report would be updated at that time.Upon receipt at our post market quality assurance laboratory, the cardiac resynchronization therapy defibrillator (crt-d) was thoroughly inspected and analyzed.Visual inspection found no anomalies.This product was put through and passed the returned products test, which involves a series of automated diagnostic testing that verifies the performance of pacing, sensing, shocking and recording functions of the device commensurate with battery voltage.The laboratory analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded code 1007, message indicator that the shocking capacitors are not charged to the programmed voltage 45 seconds after the start of charging.Reportedly, the patient was received at the emergency room due to multiple shocks inappropriately given due to atrial fibrillation with rapid ventricular response that exhausted the therapy.Technical services reviewed the case and indicated the issue could be related to an open circuit condition on the right ventricular (rv) lead.It was recommended to replace immediately this crt-d and the rv lead if the open circuit is confirmed.Subsequently, this crt-d was explanted, replaced and was returned for analysis.Reportedly, the shorted lead condition was discarded after the device data was remotely analyzed by engineering.The rv lead was working adequately.It appears that the device lost the ability to charge due to some other cause.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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