BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3163357 · Received June 11, 2013

    Report

    Report Number
    3007566237-2013-01936
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD MIGRATED AND THE PATIENT WAS HAVING REVISION SURGERY ON THE DATE OF THIS REPORT. IT WAS NOTED THAT THE LEAD MOVED CEPHALAD AND ¿THEY WILL ONLY NEED TO PULL THE LEAD DOWN SLIGHTLY.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DATE OF THE MIGRATION WAS UNKNOWN. THE COMPANY REPRESENTATIVE BECAME AWARE OF THE LEAD MIGRATION ON THE DATE OF THE CASE (2013-(B)(6)). NO OTHER MALFUNCTIONS OCCURRED. IT WAS STATED THAT THERAPY RESUMED AS NORMAL AFTER THE LEAD WAS MOVED TO THE APPROPRIATE SPINAL LEVEL. IT WAS UNKNOWN WHICH LEAD HAD MIGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263997 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention