BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANS

    MDR report key: 1250486 · Received November 26, 2008

    Report

    Report Number
    MW5009101
    Event Type
    Injury
    Date Received
    November 26, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 17, 2008
    Manufacturer
    ANS
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING PERMANENT LEADS FOR PAIN MGMT, DR DISCOVERED THE PROTECTIVE OUTER COVERING OF THE STIMULATOR BATTERY WAS DAMAGED. THIS STIMULATOR BATTERY WAS REMOVED AND REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANS PAIN STIMULATOR BATTERY LGW ANS EON

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention