BEUDAMED
    FDA Adverse Event Death Summary report: N

    N/A

    MDR report key: 2157835 · Received July 12, 2011

    Report

    Report Number
    6000094-2011-01282
    Event Type
    Death
    Date Received
    July 12, 2011
    Report Date
    November 1, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THERE WAS NO ALLEGATION THAT THE DEVICE WAS IMPLICATED IN THE DEATH OF THE PATIENT. THE DEVICE HAD BEEN INTERROGATED IN 2010 AND FOUND TO HAVE NORMAL FUNCTION. THERE WAS A QUESTION ON THE RETURNED PAPERWORK THAT SUGGESTED THE DEVICE WAS AT ELECTIVE REPLACEMENT PREMATURELY, HOWEVER IT SHOULD BE NOTED THIS INTERROGATION TOOK PLACE AFTER IT HAD BEEN REMOVED AND RETURNED TO THE CLINIC IN (B)(6) AFTER THE PATIENT HAD EXPIRED. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGATION THAT THE DEVICE WAS IMPLICATED IN THE DEATH OF THE PATIENT. THE DEVICE HAD BEEN INTERROGATED IN 2010 AND FOUND TO HAVE NORMAL FUNCTION. THERE WAS A QUESTION ON THE RETURNED PAPERWORK THAT SUGGESTED THE DEVICE WAS AT ELECTIVE REPLACEMENT PREMATURELY, HOWEVER IT SHOULD BE NOTED THIS INTERROGATION TOOK PLACE AFTER IT HAD BEEN REMOVED AND RETURNED TO THE CLINIC IN CALGARY AFTER THE PATIENT HAD EXPIRED. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. THE CHANGE IS REFLECTED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AN IMPLANTABLE PULSE GENERATOR SYSTEM DIED. IT WAS ALSO REPORTED THAT THE DEVICE HAD A PREMATURE DEPLETION OF BATTERY AS INDICATED BY THE PATIENT ALERT FOR ELECTIVE REPLACEMENT TIME. THIS ALERT WAS NOTED AT THE INTERROGATION OF THE DEVICE AFTER IT HAD BEEN REMOVED FROM THE DECEASED. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC S.A. ADDRL1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death