BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1800894 · Received August 10, 2010

    Report

    Report Number
    3007566237-2010-06006
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE OPERATION, THE LEAD COULD NOT BE FULLY INSERTED INTO THE EXTENSION. INITIALLY, THE LEAD WAS STUCK IN THE DISTAL CONNECTOR BLOCK. THE LEAD WAS INSERTED COMPLETELY WITH "A LOT OF PRESSURE" BUT IMPEDANCES WERE OVER 10,000 OHMS. THE EXTENSION WAS EXPLANTED AND REPLACED WITH DIFFICULTY REINSERTING THE LEAD INTO THE NEW EXTENSION. AFTERWARDS, IMPEDANCES WERE GOOD AND PATIENT HAD POSITIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB066157V