BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3910621 · Received July 2, 2014

    Report

    Report Number
    3004209178-2014-12469
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 10, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28, LOT# VA0C3KZ, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A STIMULATOR BUT IT WAS REMOVED BECAUSE IT WAS CAUSING THEM PAIN. IT WAS NOTED THE PATIENT¿S PAIN STARTED IN (B)(6) 2014 AND THEIR IMPLANT WAS REMOVED THE DAY PRIOR TO REPORT AND THEY HAD A TRIAL STIMULATOR PLACED THE SAME DAY. IT WAS LATER REPORTED THE PATIENT¿S DEVICE WAS WORKING GOOD THEN IT WAS TAKEN OUT DUE TO SHOCKING WHICH MADE THEM CRY DUE TO THE PAIN. IT WAS NOTED THIS STARTED TWO MONTHS PRIOR TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388180 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention