BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3971848 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13795
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 8, 2014
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4) IMPLANTED: PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 093-33, LOT# V973753, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT JUST GOT A REPLACEMENT AND GOT REWIRED. THE PATIENT SAW THE MANUFACTURER'S REPRESENTATIVE BEFORE SURGERY TO SHUT OFF THE SIDE THAT THE PATIENT DIDN'T HAVE REPLACED. THE PATIENT NOTED THIS WAS HER 15TH SURGERY WITH THE MANUFACTURER. IT WAS REPORTED THAT THE BATTERY WAS REPOSITIONED ON THE RIGHT SIDE AND THE LEAD. THE PATIENT HADN'T HAD THE RIGHT SIDE SINCE JANUARY AND THE DOCTOR WAS CONTRADICTORY ON THAT AND HAD TO DIG UP TWO CONTROLLERS AND DIDN'T KNOW IF THEY WERE PROGRAMMED OR NOT. THE PATIENT NOTED SHE HAD BEEN THROUGH THIS 15 TIMES FOR BILATERAL STIMULATION. THE PATIENT NOTED THIS WAS HER 15 - 20TH SURGERY. THE PATIENT NOTED THEY SUSPECTED THE WIRING WAS BAD AND WAS CAUSING THE PATIENT'S LEGS TO SHAKE TERRIBLY. THE NP (NURSE PRACTITIONER) DID WHAT SHE COULD TO WORK AROUND THIS BUT THEY HAD A HARD TIME DOING THIS. THE PATIENT STATED SHE WAS EXPERIENCING LOW KIDNEY FUNCTION AND CONGESTIVE HEART FAILURE. IT WAS REPORTED THAT THEY REPLACED THE RIGHT SIDE IMPLANT AND REWIRED EVERYTHING. THE LEFT SIDE INS WASN'T WORKING ALL THAT WELL AND THE HCP (HEALTHCARE PROVIDER) WAS HOPING IT WAS DUE TO WIRING WHICH GOT REDONE YESTERDAY (ON (B)(6) 2014). IT WAS ALSO NOTED THAT PATIENT BROUGHT HER OWN UNIT (PATIENT PROGRAMMER) TO THE HOSPITAL ON (B)(6) 2014 BECAUSE IT WAS DAMAGED DURING HER CAR ACCIDENT ON (B)(6) 2014. THE PATIENT NOTED SHE WAS NOW SHOWING SIGNS OF EARLY STAGE KIDNEY FAILURE AND WAS JUST HOSPITALIZED FOR CONGESTIVE HEART FAILURE. REGARDING HOW LONG AGO THE PATIENT WAS HOSPITALIZED FOR KIDNEY FUNCTION BEING LOW AND CONGESTIVE HEART FAILURE, IT WAS NOTED IT HAD BEEN THREE WEEKS. THE PATIENT NOTED SHE WAS IMPLANTED FOR BLADDER CONDITIONS AND THE FIRST TIME SHE WAS IMPLANTED (ONE OF LEFT SIDE AND ONE ON RIGHT SIDE). THE PATIENT NOTED ONE OF THE CONDITIONS THEY WOULD WORK ON TANDEM OF EACH OTHER AND WAS SOMETHING THE PATIENT HAD TO FEEL AND DOESN'T FEEL IT IN A CERTAIN SPOT THEY REPROGRAM THE STIMULATION TO REACH THE SPOT WITH BOTH OF THE PATIENT PROGRAMMERS GOING IN TANDEM. THE PATIENT STATED HER PATIENT PROGRAMMER WAS DAMAGED IN THE CAR ACCIDENT ON (B)(6) 2014 AND PART OF THE REASON WHY THE PATIENT HAD TO BE REWIRED YESTERDAY. IT WAS ALSO NOTED THAT THE PATIENT HAD 14 SURGERIES IN 3.5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446498 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| R