BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3133782 · Received May 29, 2013

    Report

    Report Number
    3006630150-2013-01108
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-50, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50C; MODEL #: SC-4316, SERIAL #: (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Additional Manufacturer Narrative · 1

    CORRECTION TO INITIAL MDR: ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOSS OF CONTROL OVER BOTH LEGS RESOLVED WITHOUT MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE NEWLY IMPLANTED PATIENT HAD NO CONTROL OF HIS RIGHT LEG WHETHER STIMULATION IS ON OR OFF. THE PHYSICIAN BELIEVED IT WAS PROCEDURE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE NEWLY IMPLANTED PATIENT HAD NO CONTROL OF HIS RIGHT LEG WHETHER STIMULATION IS ON OR OFF AND WAS ALSO HAVING TROUBLE CONTROLLING HIS LEFT LEG. THE PHYSICIAN BELIEVED IT WAS PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236809 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R