BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSA DR

    MDR report key: 2230030 · Received August 31, 2011

    Report

    Report Number
    2647346-2011-01136
    Event Type
    Death
    Date Received
    August 31, 2011
    Date of Event
    October 26, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OF NOTE THERE WAS A HAND WRITTEN ON THE RETURNED PAPERWORK THAT STATED "DAMAGE 1" AND A LINE WAS DRAWN TO THE RIGHT VENTRICULAR LEAD WHICH HAS TEST OUT OF SPECIFICATION. ATTEMPT(S) FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESS AND CONSIDERED ACCORDINGLY. EVALUATION SUMMARY: (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, ANALYZED AND THE OUTER INSULATION WAS BREACHED AND HAD ENVIRONMENTAL STRESS CRACKING. IT WAS NOTED THAT THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. 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

    TWO LEADS WERE RETURNED FROM AN UNKNOWN SOURCE ON COMPETITOR EXTRACTION PAPERWORK. THE INFORMATION STATED THE SYSTEM, THAT INCLUDED AN IMPLANTABLE PULSE GENERATOR, WAS REMOVED DUE TO INFECTION. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY ELEVEN MONTHS POST OF THE REMOVAL OF THE SYSTEM. IN ADDITION THE RIGHT VENTRICULAR LEAD WAS ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. A 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| H| R