BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1913548 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-09414
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 LEAD WAS FRACTURED CAUSING ONLY TWO OF THE FOUR PROGRAMS TO WORK. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 PROGRAMMER: MODEL 3037, LOT # NJD086732N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT # V252820| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 3095, LOT # NAH029076V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT # V252820