BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2011082 · Received March 8, 2011

    Report

    Report Number
    3006630150-2011-00303
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL BE HAVING AN NON-DEVICE RELATED SURGERY ON HIS SPINE AND WILL BE SEEING DIFFERENT PHYSICIAN REGARDING THE EXPLANT. A GOOD FAITH EFFORT WAS MADE TO REACH THE PATIENT, BUT THE ATTEMPTS WERE UNSUCCESSFUL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # - SC-2138-50 (B)(4) DESCRIPTION - LINEAR LEAD, 50 CM WITH PRE-LOADED 0.012 INCHES STYLET.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS COMPLAINING OF POCKET SITE DISCOMFORT. THE PATIENT HAS LOST A LOT OF WEIGHT. THE PATIENT MET THE PHYSICIAN AND HAS DECIDED TO EXPLANT THE SYSTEM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS COMPLAINING OF POCKET SITE DISCOMFORT. THE PATIENT HAS LOST A LOT OF WEIGHT. THE PATIENT MET THE PHYSICIAN AND HAS DECIDED TO EXPLANT THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention