Model Number D413 |
Device Problems
Signal Artifact/Noise (1036); High impedance (1291); Loose or Intermittent Connection (1371); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Electric Shock (2554)
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Event Date 03/17/2023 |
Event Type
Injury
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Manufacturer Narrative
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No additional information is available.If additional information becomes available the report will be updated at that time.
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Event Description
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It was reported that the patient received multiple inappropriate shocks post implant due to oversensing of noise.The right ventricular (rv) lead pacing impedance measurement was greater than 3000 ohms and the shocking impedance measurement was 70 ohms.A revision procedure was performed where it was noted that the rv lead was not properly inserted into the header of the implantable cardioverter defibrillator (icd).The lead was tested on the pacing system analyzer (psa) and yielded a good pacing impedance measurement of 700 ohms.During the revision, the insulation of the lead became damaged.Subsequently the rv lead was explanted and successfully replaced.The icd remains in service with the new rv lead.No additional adverse patient effects were reported.The explanted rv lead is not expected to be returned for analysis as it was contaminated during the procedure.
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Manufacturer Narrative
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No additional information is available.If additional information becomes available the report will be updated at that time.This report is being filed to correct h6 impact code and add a code that was inadvertently left off last report.
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Event Description
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It was reported that the patient received multiple inappropriate shocks post implant due to oversensing of noise.The right ventricular (rv) lead pacing impedance measurement was greater than 3000 ohms and the shocking impedance measurement was 70 ohms.A revision procedure was performed where it was noted that the rv lead was not properly inserted into the header of the implantable cardioverter defibrillator (icd).The lead was tested on the pacing system analyzer (psa) and yielded a good pacing impedance measurement of 700 ohms.During the revision, the insulation of the lead became damaged.Subsequently the rv lead was explanted and successfully replaced.The icd remains in service with the new rv lead.No additional adverse patient effects were reported.The explanted rv lead is not expected to be returned for analysis as it was contaminated during the procedure.
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Search Alerts/Recalls
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