BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4812068 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-10099
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    April 2, 2015
    Report Date
    May 11, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3093-33, LOT# VA0NPXJ, IMPLANTED: (B)(4) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UN KNOWN_PROG, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BAD FALL OFF A TREADMILL AND FOR A WHILE AFTER THEY HAD A ¿LOT OF ACCIDENTS AND URINATION¿ OVERNIGHT. THE PATIENT THEN INCREASED THE STIMULATION ON THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND THEIR SYMPTOMS IMPROVED. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR AN 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
    357063 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR