BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 5240277 · Received November 20, 2015

    Report

    Report Number
    3007566237-2015-03413
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Report Date
    September 17, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V813549, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER INDICATED FOR GASTROINTESTINAL/PELVIC FLOOR INITIALLY REPORTED THE DEVICE "DIDN'T WORK" AND THEY WANTED AN APPOINTMENT WITH THE DOCTOR. THEY DID NOT KNOW THE BATTERY WOULD NEED REPLACING. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE DEVICE WAS CHECKED ON (B)(6) 2015 AND THE MANUFACTURE REPRESENTATIVE SAID IT LOOKED LIKE THE TWO LEADS WERE NOT WORKING RIGHT. AN X-RAY WAS TAKEN TO CHECK THE LEAD PLACEMENTS WHICH SHOWED GOOD RESULTS. THE PATIENT STATED THAT THE X-RAY RESULTS DID NOT MAKE SENSE SINCE SHE FELT LEG CRAMPS HIGH UP IN HER LEG AND TINGLING IN HER BACK AND LEG. THESE SYMPTOMS MADE THE PATIENT SORE, BUT THE SORENESS WENT AWAY WHEN SHE TURNED THE DEVICE OFF. AN APPOINTMENT WAS SCHEDULED FOR (B)(6) 2015 TO TRY DIFFERENT PROGRAMS. SEE MANUFACTURE REPORT NUMBER 3004209178-2015-20053 FOR OTHER LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE REPORTED AN IMPEDANCE CHECK WAS PERFORMED INITIALLY WHICH CAME BACK FINE. THE PATIENT HAD BEEN GIVEN NEW PROGRAMS AND THE DEVICE WAS REPROGRAMMED PRIOR TO X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770430 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3093-28

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR