BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3162837 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10153
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-28 LOT# VA02EUC, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ONLY GETTING THE ¿SPLASH SCREEN¿ ON HER PROGRAMMER THE DAY PRIOR TO THE REPORT. THE PATIENT CHANGED THE BATTERIES AND WAS ABLE TO GET TO THE HOME SCREEN. THE PATIENT ALSO USED A HEATING PAD THE DAY PRIOR TO THE REPORT, AS SHE HAD DONE IN THE PAST, BUT THIS TIME EXPERIENCED A SINGLE ¿JOLTING SENSATION.¿ THE PATIENT ¿HAD NOT FELT IT YET¿ AND THEN HAD THE ISSUE WITH THE PROGRAMMER. THE PATIENT FELT THE EVENTS WERE RELATED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262497 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR