BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2992020 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03415
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 14, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA00DVR, 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 WAS 'NOT FEELING STIMULATION' AT THE TIME OF REPORT. IT WAS FURTHER REPORTED THAT THE PATIENT HAD PREVIOUSLY FALLEN AND BROKEN HER LEG. FOLLOWING THE FALL, THE PATIENT REPORTED SHE WAS 'NOT CERTAIN THAT THE STIMULATOR WAS WORKING.' IT WAS NOTED THAT THE PATIENT WAS GOING TO THE BATHROOM 'FREQUENTLY' AND HAD GONE 'SIX TIMES' DURING THE NIGHT PRIOR TO REPORT. THE PATIENT ADDITIONALLY NOTED THAT SHE WAS 'NOT GETTING A READING' FROM THE IMPLANTABLE NEUROSTIMULATOR'S (INS) 'ICON.' IT WAS FURTHER STATED THAT THE PATIENT WAS UNABLE ADJUST HER INS 'BOTH WITH OR WITHOUT ANTENNA ATTACHED.' THE PATIENT WAS REDIRECTED TO HER HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97456 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1