BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2050030 · Received March 31, 2011

    Report

    Report Number
    3004209178-2011-02445
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 23, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. NIGHT ONLY. LOSS OF BLADDER CONTROL. THE PATIENT WAS EXPERIENCING A SHOCKING OR JOLTING SENSATION. THE STIMULATION WAS TURNED DOWN, BUT THE PATIENT DIDN'T WANT TO TURN IT DOWN TOO FAR. THE SYMPTOMS OCCURRED FOLLOWING A CT SCAN, BONE SCAN, FOLLOWING A FALL. THE PATIENT FELL TWO WEEKS PRIOR. THE PATIENT WAS AT HOME AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR PROGRAMMER: MODEL 3037, LOT# NJD119087N| LEAD: MODEL 3093, LOT# V588862| IMPLANTED:| EXPLANTED: