BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4102358 · Received September 19, 2014

    Report

    Report Number
    3007566237-2014-02639
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD 3 ENTIRE SYSTEMS REMOVED AS OF RECENTLY. EACH SYSTEM WAS REMOVED BECAUSE THE IMPLANTABLE NEURO STIMULATOR (INS) WOULD MIGRATE SUPERFICIALLY. THE PATIENT ALSO NEEDED SOME MRIS BECAUSE THEY WERE HAVING BACK PROBLEMS UNRELATED TO THE IMPLANT. THE PATIENT WANTED ANOTHER SYSTEM PUT IN IF THEY COULD RESOLVE THIS RECURRENT ISSUE. THE PATIENT¿S INS HAD BUTTOCK PLACEMENT AND ALL 3 IMPLANTS WERE PERFORMED BY SEPARATE IMPLANTERS. THE PATIENT COMPLAINED OF IRRITATION ASSOCIATED WITH THE MIGRATION ON EACH OCCASION AND IT WAS UNKNOWN IF THE PATIENT HAD AN ALLERGY TO THE DEVICE OR THE EXTENT OF SKIN EROSION IF ANY. IT WAS UNKNOWN WHAT TECHNIQUES WERE USED TO MITIGATE THE MIGRATIONS AND ADVERSE EVENTS. THE PATIENT DID NOT CURRENTLY HAVE A SYSTEM IMPLANTED AND ALL COMPONENTS WERE EXPLANTED. THE PATIENT HAD GOOD RESULTS WITH THE THERAPY AND WANTED ANOTHER IMPLANT. THE PATIENT DID NOT CURRENTLY HAVE A DEDICATED HEALTH CARE PROVIDER (HCP). THE REMOVAL DATE WAS UNKNOWN. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. REFER TO MANUFACTURER'S REPORTS # 3004209178-2014-17383 <(>&<)> 3004209178-2014-17385 FOR REMOVAL OF THE PATIENT'S FIRST AND SECOND SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584265 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention