BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4210556 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20574
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    October 6, 2014
    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

    PRODUCT ID 3889-33, LOT# VA0GVDU, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3889-33, LOT# VA0GVDU, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR BLADDER AND BOWEL. THE PATIENT WAS DOING REALLY GREAT AND THEN PROBABLY ABOUT A WEEK AGO THEIR INTERNAL PAIN WAS REALLY BAD AND THE STIMULATION QUIT WORKING AND WAS NOT STIMULATING AT ALL. IT WAS NOTED THAT THE ONSET OF THE PAIN WAS SUDDEN AND THE PATIENT WASN¿T SURE IF THE STIMULATION QUITTING WAS SUDDEN BECAUSE THEY GOT USED TO THE STIMULATION AND DIDN¿T FEEL IT MUCH. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND WENT TO THEIR HEALTH CARE PROVIDER (HCP) ON 2014 (B)(6) AND THEY HAD SET IT ON PROGRAM 3 AT 1.1V AND THEY WERE SUPPOSED TO TRY IT FOR 2 WEEKS AND KEEP A RECORD OF THEIR SYMPTOMS. IT WAS REPORTED THAT PROGRAM 3 DID NOT HELP THE PATIENT¿S BOWELS AT ALL. THE PATIENT TRIED TO CHANGE IT TODAY AND AFTER SYNCING THE PATIENT REPORTED THAT THEY WERE ON PROGRAM 1 AT 5.3V AND WAS TRYING TO FEEL STIMULATION AND DID NOT FEEL STIMULATION AT ALL. IT WAS STATED THAT THE PATIENT DECREASED STIMULATION DOWN TO 3.3V BUT HAD NO DIFFERENCE IN THE PAIN LEVEL. THE PATIENT HAD TRIED PROGRAM 2 WHEN THEY WERE FIRST IMPLANTED AND ACTIVATED PROGRAM 4 AND WAS AT 0V. IT WAS REPORTED THAT THE PATIENT INCREASED TO 2.7V AND FELT NO STIMULATION. THE PATIENT¿S PROGRAMMER STOPPED SYNCING AND THE PATIENT WAS FRUSTRATED AND ENDED THE CALL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE. AN APPOINTMENT DATE OF 2014 (B)(6) WAS NOTED. THREE MONTHS LATER, IT WAS REPORTED, THE PATIENT¿S LEAD WAS REPLACED DUE TO A FRACTURE. THE PATIENT WAS EXPERIENCING A ¿GRIP¿ SENSATION THAT WOULD LET GO AND THEY WOULD LOSE STIMULATION. 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
    691926 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention