BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2191829 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05671
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 27, 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
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NEVER RECEIVED THERAPEUTIC EFFECTS FROM STIMULATION AND THAT THE THERAPY HAD NOT WORKED AS WELL AS THE PT WOULD HAVE LIKED. A LOSS OF BLADDER CONTROL WAS REPORTED FOLLOWING IMPLANT. IT WAS ALSO NOTED THAT THE PT WAS TOLD HE HAD SOME "BROKEN WIRES." ADD'L 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 EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| LEAD: MODEL 3889, LOT# J0527383V| IMPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM020246P| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH020749V| IMPLANTED: