BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2211125 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06147
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD REPOSITIONED OR DISLOCATED. A SURGICAL REVISION WAS SCHEDULED FOR A REVISION OF THE POCKET. THIS EVENT WAS DISCOVERED DURING A PHYSICAL EXAM AT A STUDY VISIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR IMPLANTED:| LEAD: MODEL 3889, LOT# V598062| PROGRAMMER: MODEL 3037, LOT# NJD119572N| EXPLANTED: