BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3642775 · Received February 24, 2014

    Report

    Report Number
    3004209178-2014-03468
    Event Type
    Injury
    Date Received
    February 24, 2014
    Date of Event
    April 28, 2006
    Report Date
    February 3, 2014
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT# V002595, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S HEALTH CARE PROVIDER (HCP) MOVING THEIR LEADS IN (B)(6) 2006 MESSED UP THE PATIENT SO THE PATIENT HAD TO GO TO ANOTHER HCP. THE NEW HCP HAD TO RE-DO THE WHOLE THING AGAIN IN (B)(6) 2006, BECAUSE SOMEHOW THE PREVIOUS REVISION WAS NOT DONE CORRECTLY. IT WAS REPORTED THAT THE PATIENT HAD A NEW DEVICE PUT IN AND THE WIRES WERE MOVED TO WHERE THEY WERE SUPPOSED TO BE WHERE IT WAS HELPING THE PATIENT. IT WAS NOTED THAT THE IMPLANT FROM 2006 WAS THE PATIENT¿S CURRENT IMPLANT AND THAT THE PATIENT HAD BEEN DOING WELL WITH THEIR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113375 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention