BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2991484 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03398
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 13, 2013
    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 3889-28, LOT# VA05GNK, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE DEVICE WAS "WORKING BEAUTIFULLY." THE PATIENT STATED THEY HAD "NO MORE CONSTANT PAIN OR DOUBLING OVER." IT WAS REPORTED, THE PATIENT WAS "GOING TO THE BATHROOM FAITHFULLY TWICE A DAY," SOMETHING THE PATIENT INDICATED THEY HAD "NOT DONE SINCE THEY WERE A CHILD." THE PATIENT ADDED THEY HAD ALWAYS BEEN CONSTIPATED. THE PATIENT ALSO NOTED THEY HAD "HAD TROUBLE SINCE THEY WERE A CHILD." IT WAS FURTHER REPORTED, THE "THERAPY WAS WORKING" AND THAT IT WAS "GOING WONDERFULLY." THE PATIENT REPORTED, THEY WERE STILL HEALING AND HAD BEEN "RAMMED INTO" BY A CART AT THE GROCERY STORE. IT WAS REPORTED, THE PATIENT "FEEL TO THEIR KNEES, DOUBLED OVER IN PAIN." THE PATIENT'S PHYSICIAN HAD SINCE CHECKED THE DEVICE AND NOTED "IT WAS FINE, NOT EVEN A BRUISE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "SHOCKING FEELING JUST BELOW THE BATTERY." IT WAS ADDITIONALLY REPORTED THAT THE PATIENT FELT "SHOCKING PAIN BELOW THE IMPLANT SITE" WHILE AT 2.3 VOLTS, BUT WAS "NOT FEELING THE SHOCKING PAIN ANYMORE" AFTER LOWERING THE STIMULATION TO 0.4 VOLTS. UPON LOWERING THE STIMULATION, THE PATIENT REPORTED THEY WERE "NOT ABLE TO COMMUNICATE WITH THE ANTENNA OR PROGRAMMER." THE PATIENT ADDITIONALLY REPORTED "NOT BEING ABLE TO ADJUST STIMULATION" INITIALLY, BUT LATER REPORTED BEING ABLE TO ADJUST STIMULATION STRENGTH. THE PATIENT ALSO STATED "SHE COULD ONLY LAY ON LEFT SIDE ON STOMACH SINCE 4AM" AT THE TIME OF REPORT. THE PATIENT WAS REDIRECTED TO THEIR HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95833 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1