BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3083609 · Received April 29, 2013

    Report

    Report Number
    3006630150-2013-00850
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S SYMPTOMS OF NUMBNESS, TINGLING, AND WEAKNESS WERE NOT CAUSED BY THE DEVICE. THE PATIENT UNDERWENT A LEAD REVISION WHEREIN THE LEADS WERE EXPLANTED AND WERE REPLACED PER THE PHYSICIAN'S PREFERENCE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS 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-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING NUMBNESS, TINGLING AND WEAKNESS IN HER LOWER EXTREMITY. THE PATIENT WILL UNDERGO LEAD REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING NUMBNESS, TINGLING AND WEAKNESS IN HER LOWER EXTREMITY. THE PATIENT WILL UNDERGO LEAD REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183510 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention