BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4953946 · Received July 30, 2015

    Report

    Report Number
    3004209178-2015-14389
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Report Date
    July 7, 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 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# VA0FKW4, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OR CHANGE OF THERAPY AND WAS COMPLETELY INCONTINENT. THE PATIENT HAD MULTIPLE SCLEROSIS (MS) AND FELL ON (B)(6) 2014 AND BROKE THEIR ANKLE. THE PATIENT HAD KIDNEY FAILURE AFTER THE SURGERY FOR THEIR ANKLE IN 2014. THE PATIENT WAS 100 PERCENT DISABLED. THE HEALTH CARE PROVIDER (HCP) WAS AWARE OF THE PATIENT'S CONDITION AND RECOMMENDED KEEPING THE IMPLANTABLE NEUROSTIMULATOR (INS) ON TO POTENTIALLY HELP WITH THE PATIENT'S CONDITION, INCLUDING BOWEL ACTIVITY. THE PATIENT'S FRIEND OR FAMILY MEMBER THOUGHT THE IMPLANT HAD BEEN WORKING, BUT WAS UNSURE OF WHEN IT CHANGED TO NOT WORK. THEY STATED IT WAS POSSIBLY AFTER THE FALL, SUBSEQUENT SURGERY, AND OTHER ISSUES. THE PATIENT WAS SCHEDULED TO HAVE A BACLOFEN PUMP IMPLANTED AND THE PATIENT'S FRIEND OR FAMILY MEMBER TRIED TO CONNECT TO SHUT IT OFF FOR THE SURGICAL PROCEDURE TOMORROW. THEY SAW A POOR COMMUNICATION SCREEN WHEN THEY TRIED TO SHUT STIMULATION OFF. THE INCISION SCAR FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS GONE AND THE PATIENT'S FRIEND OR FAMILY MEMBER WASN'T SURE WHERE THE INS WAS. THE PATIENT WAS IN A LIFT CHAIR AND COULDN'T CONNECT WITH THE PATIENT PROGRAMMER. THEY WOULD TRY TOMORROW AT THE FACILITY. NO TROUBLESHOOTING, INTERVENTIONS, OR OUTCOME 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
    498422 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1