BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4434617 · Received January 20, 2015

    Report

    Report Number
    3004209178-2015-00970
    Event Type
    Malfunction
    Date Received
    January 20, 2015
    Report Date
    January 2, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V241897, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NOT USED THEIR THERAPY IN A LONG TIME. THE PATIENT FELT STIMULATION IN THEIR BODY, EVEN WITH STIMULATION TURNED OFF. THEY EXPERIENCED A SHOCKING SENSATION WHEN IT WAS OFF. WHILE ON THE CALL, THE PATIENT CHANGED PROGRAMS, BUT STILL FELT STIMULATION IN THEIR TOES. THEY THEN DECREASED ALL PROGRAMS TO 0.0 V AND TURNED STIMULATION OFF. THE PATIENT WAS GOING TO HAVE THEIR TORN TENDON CHECKED. THE TENDON TEAR WAS DUE TO STANDING ALL DAY WHILE BEING OVERWEIGHT. THEIR TOES DID NOT MOVE OR FLEX AT ALL. THE PATIENT ALSO HAD INTERSTITIAL CYSTITIS. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46299 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1