BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2X4 CARRIER, UNKNOWN

    MDR report key: 3242346 · Received July 23, 2013

    Report

    Report Number
    3007566237-2013-02441
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 13, 2013
    Report Date
    October 12, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ISSUE OCCURRED AFTER TUNNELING. ONCE THE HEALTHCARE PROVIDER (HCP) HAD SECURED THE LEADS AND EXTENSIONS TO TUNNEL THEM UP, THE CARRIER PART BROKE AND REMAINED INSIDE THE PATIENT¿S NECK. THERE WERE NO CONSEQUENCES TO THE PATIENT. THE LEADS MIGHT HAVE BEEN DAMAGED OR DISPLACED. THERE WAS A SLIGHT LENGTHENING OF THE SURGERY DURATION BECAUSE OF THE TIME REQUIRED TO EXTRACT THE BROKEN ELEMENTS FROM THE PATIENT¿S BODY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTENSION WAS EXPLANTED DUE TO A CONNECTOR FRACTURE. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. IT WAS LATER REPORTED THAT THE EXTENSION WAS "OK." THE REPORTER STATED THAT ONLY THE CARRIER BROKE DURING USE AND THE SURGEON EXPLANTED THE "RESIDUAL SPARE OF CARRIER" AND LEFT THE EXTENSION IN PLACE AND IN USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342431 2X4 CARRIER, UNKNOWN STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 3655

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention