BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2023424 · Received March 8, 2011

    Report

    Report Number
    3004209178-2011-01719
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    April 1, 2010
    Report Date
    February 28, 2011
    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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD GOOD THERAPEUTIC EFFECT FROM THE NEUROSTIMULATOR UNTIL (B)(6) 2010 WHEN SHE LOST RELIEF. SHE MET WITH THE COMPANY REPRESENTATIVE AND HER PHYSICIAN AND WAS REPROGRAMMED. IT WAS NOTED THAT SHE HAD 2 ELECTRODES AVAILABLE. IN (B)(6) 2010, SHE MET WITH THE PHYSICIAN'S NURSE WHO TRIED TO REPROGRAM HER. THE PT SUBSEQUENTLY MET WITH THE COMPANY REPRESENTATIVE AND WAS TOLD THAT THE DEVICE BATTERY WAS DEPLETED. ADDITIONAL INFO WAS REQUESTED.

    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 55 YR IMPLANTED:| PROGRAMMER: MODEL 3037, LOT # NJD097800N| EXPLANTED:| LEAD: MODEL 3889, LOT # V379912