BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1840735 · Received September 17, 2010

    Report

    Report Number
    3004209178-2010-07079
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNING ITSELF OFF. IT WAS RECOMMENDED THAT PT SHOW THE COMPANY REP HOW SHE USED THE PT PROGRAMMER TO CONFIRM PT WAS NOT TURNING OFF THE INS HERSELF. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 51 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V109706| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD070540N