BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4466355 · Received January 29, 2015

    Report

    Report Number
    3004209178-2015-01431
    Event Type
    Injury
    Date Received
    January 29, 2015
    Date of Event
    January 8, 2015
    Report Date
    January 8, 2015
    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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V142238, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS ((B)(4)) FOUND NO ANOMALY. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S BATTERY WAS DEPLETED. BEFORE BATTERY DEPLETION, THE PATIENT COMPLAINED OF PAINFUL STIMULATION IN THEIR HEAD AND BRAIN. THE ACTION REQUIRED AS A RESULT OF THE EVENT WAS A REVISION AND THE BATTERY WAS REPLACED. THE EXPLANTED IMPLANTABLE NEUROSTIMULATOR (INS) WOULD BE RETURNED. IT WAS UNKNOWN IF DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED. THE PRODUCT ISSUE WAS RESOLVED AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT STATUS WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68155 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention