BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2890534 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-12380
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V548215, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE DEVICE WAS GIVING THE PATIENT "A LOT OF PROBLEMS AND A LOT OF PAIN." IT WAS NOTED, THE PATIENT'S NEW INSURANCE HAD "NOT APPROVED THE DEVICE YET." THE PATIENT NOTED, THE HEALTH CARE PROVIDER (HCP) "WOULD NOT DO ANYTHING UNTIL THE INSURANCE COMPANY APPROVES REFERRAL OR PRIOR AUTHORIZATION BECAUSE THEY WON'T GET PAID." IT WAS NOTED, THE PATIENT WAS "IN A LOT OF PAIN AND DOESN'T KNOW WHAT TO DO." PATIENT WAS TAKING PAIN PILLS 2-3 TIMES PER DAY FOR THE PAIN. IT WAS NOTED AN X-RAY WAS TAKEN IN AUGUST AND THE HCP "DID NOT THINK ANYTHING MOVED OR WAS WRONG." IT WAS ALSO NOTED, THE HCP THINKS THE IMPLANT MAY BE PRESSING UP AGAINST A NERVE AND THAT COULD BE CAUSING THE PAIN. PATIENT NOTED "THEY NEED TO GET THE DEVICE REMOVED." THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. THE PATIENT COULD NO LONGER EXERCISE AT ALL DUE TO THE PAIN AND HAD BEEN WALKING FOUR MILES A DAY PRIOR TO THE PAIN. IT WAS ALSO NOTED THIS WAS CAUSING A WEIGHT PROBLEM DUE TO NOT BEING ABLE TO EXERCISE. IT WAS NOTED ALL THE PAIN AND CHANGE IN THE PATIENT'S ROUTINE STARTED BACK IN (B)(6) 2012. THE PATIENT HAD NOT FALLEN AND HAD NOT DONE ANY HEAVY DUTY LIFTING. NO MEDICAL PROCEDURES WERE DONE; THE LAST MEDICAL PROCEDURE WAS THE IMPLANT OF THE DEVICE. IT WAS NOTED, THE DEVICE WAS TURNED OFF (B)(6) 2012. WHEN STIMULATION WAS TURNED OFF IT "FELT A LITTLE BETTER, BUT IT HAD NOT REALLY HELPED WITH THE PAIN." IT WAS CONFIRMED, THE DEVICE WAS OFF AND THE STIMULATION WAS AT 0.0 VOLTS. IT WAS ALSO NOTED, THE PATIENT KNEW THE DEVICE WAS OFF BECAUSE THEY COULD FEEL THE STIMULATION WHEN IT WAS ON. AFTER REVIEW OF PATIENT PROGRAMMER IT WAS NOTED, THE PATIENT WAS ON PROGRAM 3 AT 1.5 VOLTS. THE PATIENT THEN ADJUSTED THEIR SETTING DOWN TO 0.0 VOLTS AND TURNED THE PATIENT PROGRAMMER OFF AGAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention