BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2989182 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03299
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-33 LOT# V240181, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "A BATTERY ON ITS SIDE" ICON WAS SHOWN ON PATIENT PROGRAMMER SCREEN. IT WAS STATED THAT THE PATIENT THOUGHT HER INS NEEDED TO BE CHANGED. TEN DAYS LATER, IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS LOW BATTERY. THE ISSUE WAS BATTERY DEPLETION. BATTERY REPLACEMENT HAD OCCURRED. LOW BATTERY MESSAGE WAS ASSOCIATED WITH THE EVENT. SURGICAL NOTES STATE DIAGNOSIS WAS MALFUNCTIONING INS. OPERATIVE PERMIT FOR LEAD REVISION AND BATTERY CHANGE WAS NOTED. NO INJURY WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94404 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Required Intervention