BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2682913 · Received August 6, 2012

    Report

    Report Number
    3004209178-2012-06504
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Report Date
    July 9, 2012
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V963187, IMPLANTED: (B)(6) 2012. 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 EXPERIENCED A SHOCKING OR JOLTING SENSATION. ABOUT 2.5-3 WEEKS AFTER IMPLANT, WHILE THE PATIENT WAS STANDING UP SHE EXPERIENCED AN AWFUL PAIN ON THE RIGHT SIDE OF HER VAGINA TO "LOWER ABL." IT WAS DESCRIBED THAT IT FELT LIKE A BLADDER SPASM. THE PATIENT ALSO HAD NUMBNESS IN HER VAGINA. THE PATIENT TURNED OFF STIMULATION BUT THE PATIENT WAS WEAK AND HURTING AND IT TOOK A WHILE TO RECOVER. PRIOR TO THE INCIDENT THE PATIENT WAS ALSO NOT HAVING COMPLETE THERAPEUTIC EFFECT, BUT THE INCIDENT DECREASED THERAPY. THE PATIENT WAS GETTING ABOUT 40% IMPROVEMENTS AT THE TIME OF REPORT. THE PATIENT REPORTED FALLING THREE TIMES IN ONE DAY IN THE LAST WEEK. FOR ONE OF THE FALLS THE PATIENT PASSED OUT AND FELL FORWARD. THE PATIENT WAS DIAGNOSED WITH ATRIAL FIBRILLATION AND WAS ON COUMADIN. IT WAS REPORTED PROGRAMMER TRAINING WAS INEFFECTIVE DUE TO THE EFFECTS OF ANESTHESIA AFTER THE PROCEDURE. THE PATIENT SWITCHED PROGRAMS AND FOUND A SETTING THAT STIMULATED THE RIGHT AREAS. THE PATIENT WAS GOING TO MONITOR SYMPTOMS. THREE WEEKS LATER IT WAS REPORTED THAT THE PATIENT WAS NOT SATISFIED WITH HER RESULTS. THE PATIENT STILL HAD CONCERNS WITH HER DEVICE OR THERAPY AND HAD REQUESTED A MANUFACTURER'S REPRESENTATIVE TO COME TO A PHYSICIAN APPOINTMENT THAT HAD NO REPORTED SCHEDULED DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1