BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LEAD

    MDR report key: 3770612 · Received April 24, 2014

    Report

    Report Number
    3007566237-2014-01136
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    February 9, 2012
    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 PATIENT RECEIVED AN INVITATION TO THE HOSPITAL FOR REMOVAL OF THE LEAD BECAUSE THERE WERE NEW SYMPTOMS. IT WAS NOTED THE PATIENT HAD A FEELING OF ELECTRICAL SHOCKS ON THE NECK AND A DISAPPEARANCE OF MOVEMENT CONTROL. IT WAS FURTHER REPORTED THAT THE PATIENT WAS AFRAID OF EXPLANTING THE REST OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250068 UNKNOWN LEAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention