BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2864072 · Received December 10, 2012

    Report

    Report Number
    3007566237-2012-02951
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    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

    PRODUCT ID 3093, EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE LEAD REMOVAL PROBLEMS. IT WAS STATED THAT THE HEALTH CARE PROVIDER (HCP) CHOSE TO DO A LEAD REVISION DUE TO THE FACT THAT IT HAD "MIGRATED INWARDS SIGNIFICANTLY." THE REMOVAL REPORTEDLY BECAME DIFFICULT AS ALL THE TINES WERE WITHIN THE FORAMEN. IT WAS STATED THAT THE LEAD SNAPPED AND PARTIALLY REMAINED WITHIN THE PATIENT. IT WAS INDICATED THAT IT WOULD BE A MAJOR SURGERY TO REMOVE THE REMAINING HALF OF THE LEAD. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. NO FURTHER INFORMATION WAS GIVEN. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention