BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2881891 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12086
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 30, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# V569218, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THAT THE PATIENT HAD A NEW SYSTEM IMPLANTED. IT WAS NOTED THAT THE PATIENT FELL ON HER DEVICE 2 TIMES AND THE DEVICE WAS DAMAGED AFTER THE SECOND FALL. IT WAS STATED THAT THE PATIENT IS NOW RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION FOLLOWING A FALL. IT WAS STATED THAT THE PATIENT FELL ON HER BACK 8 MONTHS AGO AND STIMULATION HAD NOT BEEN WORKING SINCE THAT TIME. FURTHER INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention