Model Number E110 |
Device Problems
Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Telemetry Discrepancy (1629); Defective Device (2588)
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Patient Problems
Bruise/Contusion (1754); Pain (1994); Anxiety (2328); Electric Shock (2554); No Code Available (3191)
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Event Date 03/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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This product has been received for analysis.This report will be updated should further information become available.
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Event Description
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It was reported that this device delivered multiple inappropriate shocks.This device was also noted to have exhibited premature battery depletion and recorded a code 1007.This device was then explanted and replaced.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, visual inspection of the device identified scratches and dents on the device case.Review of device memory found a charge time exceeded fault was recorded after multiple shocks were delivered.The device battery status moved to end of life (eol) due to long charge times.An x-ray of the device revealed that the internal high voltage fuse was damaged (i.E., no longer intact).The damage to the fuse most likely occurred during delivery of the shock that resulted in the shorted shock lead error.The damage to the high voltage fuse prevented any subsequent charging of the high voltage capacitors and delivery of shock therapy.As a result, the device declared eol because it could not successfully complete charging within 30 seconds, despite the fact that significant battery voltage and capacity remained.Code 3191 was used to capture surgical intervention.
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Event Description
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It was reported that this implantable cardioverter defibrillator could not be interrogated.It was noted that the patient had been shocked multiple times.On the explant form it was noted that the device had declared a code 1007, indicative of a potential lead issue and premature battery depletion was suspected.The device was explanted and returned for analysis.No additional adverse patient effects were reported at this time.Additional information from the patient provided more detail about the event.He noted that he had presented to the emergency room after receiving a shock, which reportedly caused bruising and pain.The patient stated that this shock depleted the device battery.He also reported anxiety due to the situation.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, visual inspection of the device identified scratches and dents on the device case.Review of device memory found a charge time exceeded fault was recorded after multiple shocks were delivered.The device battery status moved to end of life (eol) due to long charge times.An x-ray of the device revealed that the internal high voltage fuse was damaged (i.E., no longer intact).The damage to the fuse most likely occurred during delivery of the shock that resulted in the shorted shock lead error.The damage to the high voltage fuse prevented any subsequent charging of the high voltage capacitors and delivery of shock therapy.As a result, the device declared eol because it could not successfully complete charging within 30 seconds, despite the fact that significant battery voltage and capacity remained.Code 3191 was used to capture surgical intervention.This report is being filed to note that additional investigation is being conducted regarding the nature of the therapy delivery initially reported as inappropriate.This information will be updated at that conclusion of that investigation.
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Event Description
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It was reported that this implantable cardioverter defibrillator could not be interrogated.It was noted that the patient had been shocked multiple times.On the explant form it was noted that the device had declared a code 1007, indicative of a potential lead issue and premature battery depletion was suspected.The device was explanted and returned for analysis.No additional adverse patient effects were reported at this time.Additional information from the patient provided more detail about the event.He noted that he had presented to the emergency room after receiving a shock, which reportedly caused bruising and pain.The patient stated that this shock depleted the device battery.He also reported anxiety due to the situation.
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Search Alerts/Recalls
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