BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3625317 · Received February 12, 2014

    Report

    Report Number
    3006630150-2014-00278
    Event Type
    Injury
    Date Received
    February 12, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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), PRODUCT DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM; MODEL #: SC-4316, LOT #: 16224240, PRODUCT DESCRIPTION: NEXT GENERATION ANCHOR KIT. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-50, SERIAL #: (B)(4), PRODUCT DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM. MODEL #: SC-4316, LOT #: 16224240, PRODUCT DESCRIPTION: NEXT GENERATION ANCHOR KIT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING THE SYMPTOMS OF MYELOPATHY. SYMPTOMS INCLUDE WEAKNESS IN LEGS AND A BAD FEELING AROUND HER ABDOMEN. THE PHYSICIAN BELIEVED THAT IT WAS PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING THE SYMPTOMS OF MYELOPATHY. SYMPTOMS INCLUDE WEAKNESS IN LEGS AND A BAD FEELING AROUND HER ABDOMEN. THE PHYSICIAN BELIEVED THAT IT WAS PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91984 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention