BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1840769 · Received September 17, 2010

    Report

    Report Number
    3004209178-2010-07082
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE THE STIMULATION WAS TURNED ON THERE WAS A LOSS OF THERAPEUTIC EFFECT. THERE WAS LEAKING AND FREQUENT BATHROOM TRIPS ONE DAY AND NO PROBLEMS THE NEXT DAY. CALLER WAS UNCERTAIN WHETHER THEY SHOULD BE DRINKING OR NOT. CALLER ALSO INDICATED THAT THEY DID NOT USE THE PATIENT PROGRAMMER AS WAS SHOCKED ONE TIME FROM USING IT AND HADN'T USED IT SINCE. CALLER HAD NOT TOLD HER PHYSICIAN ABOUT THIS. PATIENT REPORTED SPURTS OF GETTING EXTREMELY HOT AND THEN IT WENT AWAY, ALONG WITH LEG CRAMPS WHICH THEY RUBBED TO RELIEVE THE PAIN. THIS EVENT OCCURRED AFTER A FALL. PATIENT INDICATED A FALL FORWARD ON HER HANDS AND KNEES IN WHICH THEY LAID THERE FOR A WHILE AND DID NOT TELL ANYONE THAT THEY FELL. THE DEVICE PROBLEMS WERE OCCURRING BEFORE AND AFTER THE FALLS. ADDITIONAL INFORMATION 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 MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095, LOT #NAH044513V| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT #NJD107432N| LEAD: MODEL 3093, LOT #V470187