BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2230441 · Received August 15, 2011

    Report

    Report Number
    3007566237-2011-06354
    Event Type
    Injury
    Date Received
    August 15, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LEAD FRACTURE. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR SYSTEM WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE SYSTEM. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL UNK, LOT# UNK