BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5765448 · Received July 1, 2016

    Report

    Report Number
    3004209178-2016-13388
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    June 11, 2008
    Report Date
    July 1, 2016
    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
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT#: V120757, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. ANALYSIS OF THE STIMULATOR ((B)(4)) FOUND THAT THE STIMULATOR WAS FUNCTIONALLY OKAY. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PATIENT VIA A COMPANY REPRESENTATIVE REPORTED THAT THEY HAD THE DEVICE REMOVED BECAUSE IT DID NOT WORK AT ALL. THE INDICATIONS FOR USE FOR THIS PATIENT WERE URINARY DYSFUNCTION/SACRAL NERVE STIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419429 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention