BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5244649 · Received November 23, 2015

    Report

    Report Number
    3004209178-2015-23301
    Event Type
    Injury
    Date Received
    November 23, 2015
    Report Date
    October 27, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V183295, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE PATIENT HAD "SKIN PROBLEMS RAW IN THE BACK" AND HAD A REPLACEMENT. THE SKIN PROBLEMS BEGAN "POSSIBLY" AROUND (B)(6) 2009. THE INDICATION FOR USE INCLUDED URINARY DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774995 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention