BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NEUROMODULATION

    MDR report key: 3596740 · Received January 29, 2014

    Report

    Report Number
    3007566237-2014-00314
    Event Type
    Injury
    Date Received
    January 29, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 28, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE CAUSE OF THE EVENT WAS THE TOOL TIP MAY NOT HAVE BEEN FULLY TIGHTENED. IT WAS STATED THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. IT WAS STATED THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE TUNNELING TOOL TWISTED OFF DYING MANIPULATION OF THE TUNNELING TOOL THAT RESULTED IN THE TIP REMAINING IN THE NECK. THIS REQUIRED ANOTHER UNPLANNED INCISION TO RETRIEVE THE TIP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPORTER BELIEVED THAT THE TIP WAS UNTWISTED IN SURGERY DUE TO REPETITIVE TWISTING MOTION TO ATTEMPT TO MAKE THE TUNNELING PROCESS EASIER. IT WAS NOTED THAT THERE WERE NO UPDATES ON THE PATIENT. IT WAS NOTED THAT NO PRODUCT WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63219 MEDTRONIC NEUROMODULATION STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 3755 N416636

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention