BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2594667 · Received May 31, 2012

    Report

    Report Number
    3004209178-2012-03877
    Event Type
    Injury
    Date Received
    May 31, 2012
    Report Date
    May 23, 2012
    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
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-33, LOT# V020254, SERIAL#, IMPLANTED: 2007 (B)(6), EXPLANTED, PRODUCT TYPE: LEAD, PRODUCT ID 3095-10, LOT#, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED, PRODUCT TYPE: EXTENSION, PRODUCT ID 3037, LOT#, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT TRIED BOTH PROGRAMS ON THE IMPLANTABLE NEUROSTIMULATOR (INS) WITHOUT RESULTS AND TURNED THE INS OFF. REVISION SURGERY WAS PERFORMED THE WEEK OF (B)(6). THE LEAD HAD MIGRATED AND WAS REPLACED. THE INS WAS ALSO REPLACED AS IT WORE DOWN DUE TO THE HIGH SETTINGS AND LEAD MIGRATION. THE LEAD MIGRATION WAS POSSIBLY DUE TO A PATIENT FALL. AN ADDITIONAL FACTOR WAS THAT THE PATIENT WAS "PRETTY SICKLY" AND TENDED TO HAVE MANY PROBLEMS. THE OUTCOME OF THE PATIENT WAS GOOD AND HE WAS FEELING STIMULATION IN THE CORRECT SPOT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention