BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3050523 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05867
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 20, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3093-33, LOT# V449147, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT# V449877, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THE DEVICES HAD BEEN OFF FOR A YEAR. EVERY TIME THE PATIENT TRIED TO ADJUST OR CHANGE THE SETTINGS THE DEVICE WOULD BURN THE PATIENT. THE PHYSICIAN TOLD THE PATIENT THAT HE HAD DONE EVERYTHING HE COULD. THE PATIENT HAD TRIED MAKING ADJUSTMENTS BUT WAS ONLY FEELING MORE BURNING PAIN. THE PATIENT WAS IMPLANTED FOR FREQUENCY AND BURNING PAIN WITH URINATION. DURING THE TRIAL THE FREQUENCY WAS NOT REDUCED, BUT THE BURNING HELPED SOME. THE BURNING WAS BACK AND THE FREQUENCY HAD NEVER BEEN RELIEVED. THE PATIENT WANTED THE DEVICES REMOVED. THE PATIENT HAD AN APPOINTMENT WITH A HEALTHCARE PROFESSIONAL. THE PATIENT HAD SEEN MANUFACTURER'S REPRESENTATIVES WHO HAD TRIED REPROGRAMMING AND THEN GAVE UP. THE PATIENT WAS IN A WHEEL CHAIR AND COULD NOT WALK. THE PATIENT WAS (B)(6) AND THEY WERE NOT SURE IF THE PATIENT COULD HAVE ANOTHER SURGERY AND ANESTHESIA. THEY HAD RECEIVED A SECOND OPINION AND THE ONLY ADVICE FOR THE PATIENT WAS TO TURN THE DEVICES OFF. THE PT HAD A CT SCAN TO DETERMINE IF THE WIRES MIGRATED OR NOT. THE HEALTHCARE PROVIDER SAID THE LEADS WERE IN PLACE AND IN WORKING ORDER BASED ON THE CT SCAN. THE PT WAS NOT SURE IF THEY SHOULD TRY AND TURN THE DEVICES BACK ON OR HAVE THEM REMOVED. THEY WOULD LIKE TO HAVE THEM IN WORKING ORDER. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2013-05865.

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE PATIENT¿S HEALTHCARE PROVIDER INDICATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THAT THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. THE REPORTER INDICATED THAT THE INDICATION OF THE DEVICE WAS SCROTAL NEURALGIA. THE DEVICE WAS REPORTEDLY NOT HELPING FOR THIS AND WAS TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153945 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1