BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSA DR

    MDR report key: 1959450 · Received January 13, 2011

    Report

    Report Number
    2647346-2011-00017
    Event Type
    Death
    Date Received
    January 13, 2011
    Date of Event
    November 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED CUT AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED CUT AND THERE WAS APPARENT EXPLANT DAMAGE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED CUT AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED CUT AND THERE WAS APPARENT EXPLANT DAMAGE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY SEVEN MONTHS POST IMPLANT OF THE IMPLANTABLE PULSE GENERATOR. IT WAS FURTHER REPORTED THAT THE PATIENT WAS LAST SEEN IN THE DEVICE CLINIC APPROXIMATELY 1 MONTH PRIOR DEATH. AT THE VISIT THE DEVICE WAS INTERROGATED AND FOUND TO HAVE NORMAL PARAMETERS. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. VEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death| O