BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4143469 · Received October 6, 2014

    Report

    Report Number
    3004209178-2014-18321
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    September 15, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3889-28, LOT# J0455453V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING. IT QUIT WORKING THE OTHER DAY, CALLER CLARIFIED A COUPLE DAYS AGO. THE PATIENT WAS HAVING PAIN BECAUSE IT WAS NOT WORKING. THEY HAVE IT ON HIS BACK TO SEE IF THEY COULD STIMULATE HIS BACK TO KEEP HIM FROM URINATING AND TO HELP WITH HIS BACK. THE ONLY THING THAT SHOWED WAS THAT THE BATTERY WAS WORKING. THE PATIENT DID NOT FEEL STIM. THERE WAS NO LIGHT NEXT TO INS BATTERY. THE PATIENT NOTED HE HAD THE DEVICE IMPLANTED TO HELP WITH BACK PAIN ON L 4, 5 AND 6. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623204 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR