BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1910622 · Received November 19, 2010

    Report

    Report Number
    3004209178-2010-09810
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    November 17, 2009
    Report Date
    November 12, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S NEUROSTIMULATOR REACHED END-OF-LIFE (EOL) AFTER BEING IMPLANTED FOR 8 MONTHS. THE DEVICE WAS REPLACED. ADDITIONAL INFO WAS REQUESTED. SEE MFR REPORT # 3004209178201009812 FOR PREVIOUS NEUROSTIMULATOR BATTERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention PROGRAMMER: MODEL 3037, LOT# NJD081443N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V189561