BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4847960 · Received June 16, 2015

    Report

    Report Number
    3004209178-2015-11673
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Report Date
    May 26, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V840309, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3889-28, LOT# V840309, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S THERAPY WORKED FOR A WHILE AFTER IMPLANT, BUT THEIR SYMPTOMS STARTED TO RETURN IN (B)(6) 2012. THE PATIENT STARTED GOING TO THE BATHROOM 6 TO 7 TIMES AT NIGHT AND WITHIN THE LAST 6 MONTHS THEY WERE NOW INCONTINENT DURING THE DAY. THE PATIENT HAD FALLEN 3 TIMES IN 2014; THE FIRST TIME THEY FELL DIRECTLY ON THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE LAST 2 THEY DID NOT FALL ON THE DEVICE AND FELL ON THEIR KNEES. THE PATIENT WAS NOW IN A WHEELCHAIR AND WAS GOING TO HAVE A TOTAL KNEE REPLACEMENT. THE PATIENT HAD THE DEVICE CHECKED AFTER THE FALL AND WAS TOLD THAT ONE OF THE LEADS WAS BROKEN AND NOT WORKING CORRECTLY. THE PATIENT WAS NOT SURE WHY THE HEALTH CARE PROVIDER (HCP) HAD NOT DONE ANYTHING ABOUT IT. THE PATIENT WAS TOLD THE LEAD WAS BROKEN 4 MONTHS AGO. NO OUTCOME OR INTERVENTIONS WERE 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
    392386 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1