BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2190732 · Received July 26, 2011

    Report

    Report Number
    3007566237-2011-05796
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    May 19, 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). ANALYSIS OF THE ADAPTOR MODEL 74001, LOT# 0203436831 SHOWED THAT NO ANOMALY WAS FOUND .THE ADAPTOR WAS FUNCTIONALLY OK. NO VISUAL ANOMALIES. SETSCREW IMPRESSIONS WERE OBSERVED ON THE #0 CONNECTOR SLEEVE, THAT INDICATED THAT THE ADAPTOR WAS IMPLANTED CORRECTLY. THE CONTINUITY WAS ACCEPTABLE WITH NO SHORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT THE STIMULATION IN THE AREA OF THE IMPLANTABLE NEUROSTIMULATOR (INS), BUT DID NOT FEEL A "PROPER STIMULATION." IT WAS FOUND THAT THE ADAPTOR CAUSED THE ISSUE AND WAS, THEREFORE, REMOVED AND REPLACED. THE PATIENT'S OUTCOME WAS NOTED TO BE "OK."

    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 61 YR Required Intervention ADAPTOR: MODEL 74001, LOT# 0203436831| EXPLANTED:| IMPLANTED: