BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1621612 · Received February 25, 2010

    Report

    Report Number
    MW5014948
    Event Type
    Injury
    Date Received
    February 25, 2010
    Date of Event
    February 4, 2010
    Report Date
    February 25, 2010
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAS A EPS AICD IMPLANTATION ON (B) (6) 2007. WITH REPROGRAMMING REQUIRED IN (B) (6) 2010. NO FURTHER COMPLICATIONS UNTIL EVIDENCE OF IMPENDING LEAD FRACTURE IN (B) (6) 2010. ICD LEAD WAS EXPLANTED AND REPLACED WITH A NEW MEDTRONIC MODEL # 6847-58 LEAD CONNECTED TO THE PRE-EXISTING MEDTRONIC ENTRUST MODEL D154VRC PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC AICD LEAD LWS RT VENTRICLE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability