BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3773003 · Received April 25, 2014

    Report

    Report Number
    3004209178-2014-08101
    Event Type
    Injury
    Date Received
    April 25, 2014
    Report Date
    April 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 093-33, LOT# V250971, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT铠DEVICE WAS REMOVED DUE TO IT NOT HELPING WITH THEIR SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LASTED 6 MONTHS THEN IT GOT KNOCKED OUT AND PATIENT¿S HEALTH CARE PROVIDER (HCP) PUT IT IN AGAIN. THE PATIENT WAS FIRST IMPLANTED ON 2009-08-05 AND THEN PROBABLY A YEAR OR A YEAR AND A HALF LATER THE PATIENT HAD THE SECOND SURGERY. IT WAS NOTED THAT THE PATIENT WAS NOT REALLY SURE IF THAT DATE WAS CORRECT. THE IMPLANT WORKED FOR ABOUT 6 MONTHS THEN THE PATIENT WAS SENT IN FOR X-RAYS AND THEIR HCP STATED THAT THE IMPLANT HAD MOVED SO THEY DID IT AGAIN. IT WAS REPORTED THAT THE PROBE WASN¿T CONNECTED RIGHT TO WHATEVER IT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251612 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention