BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2615901 · Received June 14, 2012

    Report

    Report Number
    3004209178-2012-04461
    Event Type
    Malfunction
    Date Received
    June 14, 2012
    Report Date
    May 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-33 LOT# V963207, IMPLANTED: 2012 (B)(6), EXPLANTED: 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 COULD NOT ADJUST THE STIMULATION ON THE IMPLANTABLE NEUROSTIMULATOR (INS) AND REPORTED SEEING A "CALL YOUR DOCTOR" MESSAGE ON THE PATIENT PROGRAMMER. A POWER ON RESET (POR) CONDITION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT REPROGRAMMING WAS DONE TO RESOLVE THE ISSUE. THE CAUSE OF THE POR CONDITION WAS THAT THE CLINICIAN GOT TOO CLOSE TO THE INS WITH BOVINE. THE POR WAS EFFECTIVELY CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1