BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1231239 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07440
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    June 1, 2008
    Report Date
    October 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S DEVICE WOULD TURN OFF EVERY DAY. THE PT WOULD USE HER PT PROGRAMMER TO TURN IT BACK ON BUT IT WOULD TURN OFF 15-20 MINUTES LATER. WHEN THE PT FIRST RECEIVED THE DEVICE, IT WAS REPORTED THAT IT WORKED GREAT. SHE HAS GONE TO HER PHYSICIAN SEVERAL TIMES TO HAVE HER DEVICE TURNED BACK ON. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR LEAD: MODEL 3889| EXTENSION: MODEL 3095| PROGRAMMER: MODEL 3031A| EXPLANTED:| EXPLANTED: