BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3526364 · Received December 18, 2013

    Report

    Report Number
    3004209178-2013-23737
    Event Type
    Injury
    Date Received
    December 18, 2013
    Report Date
    December 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28 LOT# V850461, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD AN INFECTION TWO MONTHS PRIOR TO REPORT AND ANTIBIOTICS CLEARED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661612 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention