BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3885144 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11838
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    May 29, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT# VA0364U, IMPLANTED: 2012 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3093-33, LOT# VA0364U, IMPLANTED: 2012 (B)(6), EXPLANTED: 2014 (B)(6); 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 STATES AROUND 3 MONTHS AGO IT STOPPED WORKING AND STARTED CAUSING PAIN IN HER RIGHT LEG. SHE COULDN'T WALK OR PUT WEIGHT ON THE RIGHT SIDE. SHE TURNED IT OFF AND THE PAIN WENT AWAY. SHE TURNED IT ON 2 WEEKS AGO AND THE PAIN GOT REAL BAD IN HER LEG AGAIN, SHE WENT TO HEALTHCARE PROVIDER OFFICE LAST THURSDAY. SHE FOUND OUT HER MAIN LEAD WIRE WAS BROKEN, SHE WENT IN TO THE HOSPITAL ON THREE DAYS BEFORE REPORTED EVENT DATE AND HAD INS (STIMULATOR) AND LEAD REPLACED. THE PATIENT STATES NO FALLS OR ACCIDENTS. THE PATIENT WANTED TO KNOW IF THE LEADS WERE ON THE RECALL LIST. IT WAS CONFIRMED INS AND LEADS SHOWED NO RECALLS. THE PATIENT STATES THE REPRESENTATIVE SAID THERE WAS NO REASON FOR THE LEAD TO BREAK UNLESS THERE WAS A FALL. IT WAS EXPLAINED TO THE PATIENT LEADS CAN FRACTURE OR BREAK DUE TO ACTIVITY OF THE PATIENT AS WELL. THE PATIENT MENTIONS SHE SEEN A RECALL ONLINE FOR THE PROGRAMMER CLASS 3 AND IT WAS FOR A FALSE BATTERY STATUS. IT WAS EXPLAINED THIS RECALL WAS FOR THE PROGRAMMER AND NOT A DEVICE RECALL. THE PATIENT STATES HER PATIENT PROGRAM SHOWED THE BATTERY WAS LOW AND WHEN THEY WENT TO THE HCP (HEALTHCARE PROVIDER) TO HAVE THE DEVICE READ IT WAS NEEDING TO BE REPLACED AFTER A YEAR AND FEW MONTHS. THE PATIENT STATES, THE MANUFACTURER REPRESENTATIVE SAID IT SHOULDN'T HAVE BEEN THAT LOW IT'S AT 60%. BATTERY LONGEVITY WAS REVIEWED AND THE PATIENT FEELS THERE WAS A DEFECT ON THE INS (STIMULATOR). THE PATIENT REPORTS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT MENTIONS THE PAIN STARTED (B)(6) 2013, SHE TRIED EVERY PROGRAM AND IT WAS NOT WORKING FOR HER AND SHE ASKED ¿IT BE TURNED OFF¿. TOWARDS THE END OF THE CALL SHE MENTIONS 2 WEEKS AGO IT WAS TURNED OFF BECAUSE ON THE LEFT SIDE LEG UNDER HER BUTTOCKS AND IT WAS CAUSING PAIN. THE PATIENT MENTIONS HAVING LOTS OF SURGERIES AND HAVE A SLING IMPLANTED THEN GETTING THE INS. THE PATIENT WOULD LIKE TO HAVE THE INS AND LEAD SENT BACK TO MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361445 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention