BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3082178 · Received April 29, 2013

    Report

    Report Number
    3007566237-2013-01453
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THEIR DEVICE EXPLANTED TWO YEARS PREVIOUS. WHEN THE SYSTEM WAS EXPLANTED, A PORTION OF THE LEAD REMAINED IN THE PATIENT'S BODY. ABOUT A WEEK LATER, IT WAS REPORTED THAT THE LEAD "FRAGMENTS" WERE SEEN UPON DOING A REGULAR X-RAY FOR AN MRI. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    AFTER ADDITIONAL REVIEW, IT WAS REPORTED THAT THE PATIENT NEEDED AN MRI. IT WAS NOTED THAT THEY TOOK THE DEVICE OUT FOR THE MRI. UPON TAKING THE DEVICE OUT, THEY NEVER TOOK THE WHOLE LEAD OUT. IT BROKE IN THE PATIENT AND THE HEALTHCARE PROVIDER NEVER EXTRACTED THE ENTIRE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184624 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other