BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2113829 · Received May 17, 2011

    Report

    Report Number
    3004209178-2011-03592
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED PAIN AT THE IMPLANT SITE AND A LOSS OF THERAPEUTIC EFFECT. SHE WAS INSTRUCTED TO RUN THE DEVICE OFF. SHE MET WITH HER PHYSICIAN AND THE DEVICE WAS INTERROGATED. HIGH IMPEDANCES (>4000 OHMS) WERE SEEN IN ELECTRODE #0 WHILE ALL OF THE OTHER ELECTRODES WERE WITHIN NORMAL RANGE. NO SIGNS OF INFECTION WERE SEEN, BUT SHE STILL HAD THE PAIN AT THE DEVICE SITE, ALTHOUGH IT HAD IMPROVED SLIGHTLY WITH THE DEVICE OFF. THE PATIENT WAS INSTRUCTED TO LEAVE THE DEVICE TURNED OFF FOR 3 TO 5 DAYS. IF THE PAIN SUBSIDED SHE COULD THEN USE THE DEVICE (A NEW PATIENT PROGRAMMER WAS ALSO GIVEN TO THE PATIENT) OTHERWISE SHE WAS TO TURN THE DEVICE OFF AND CALL HER PHYSICIAN BACK. ADDITIONAL INFORMATION 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 59 YR LEAD: MODEL 3889, LOT# V319870| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD095098N