BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2190756 · Received July 26, 2011

    Report

    Report Number
    3007566237-2011-05797
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S EXTENSION WAS EXPLANTED AND REPLACED DUE TO A SUSPECTED FRACTURE. NO FURTHER DETAILS OR PATIENT SYMPTOMS WERE PROVIDED. THERE WAS NO PATIENT INJURY.

    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 IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# UNKNOWN