BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2943905 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-01305
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 16, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V639198, 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 HAD A "BAD" FALL ON (B)(6) 2012 AND HAD TO HAVE HIS SHOULDER REPLACED DUE TO THE FALL. THE PATIENT'S DEVICE WAS HOWEVER, NOT CHECKED AFTER THE FALL. THE PATIENT FELL AGAIN TWO WEEKS PRIOR TO THE REPORT, ON (B)(6) 2013. OVER THE LAST 7 TO 10 DAYS, THE PATIENT'S SYMPTOMS SEEMED TO HAVE BEEN BACK TO WHERE THEY WERE BEFORE THE PATIENT WAS IMPLANTED. THE PATIENT TURNED STIMULATION UP TO 8.7V BUT FELT NO STIMULATION SENSATION EXCEPT A "DULL ACHE" OVER THE DEVICE. THE REPORTER STATED THAT THE PATIENT WAS URINATING 10 TO 20 TIMES PER DAY. UP TO 3 WEEKS PRIOR TO THE REPORT, THE PATIENT HADN'T USED THE PROGRAMMER TO CHECK HIS DEVICE SETTINGS. AT THE TIME OF THE REPORT, THE PATIENT WAS ON PROGRAM 1. WHEN STIMULATION AMPLITUDE WAS INCREASED ON PROGRAM 2, THE PATIENT STILL FELT NO STIMULATION. THE REPORTER INDICATED THAT THE PATIENT USUALLY RAN STIMULATION AROUND 2.5V. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49338 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1