BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4130906 · Received September 30, 2014

    Report

    Report Number
    3006630150-2014-02229
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    June 20, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE RAISED AREA IN THE LOWER PORTION OF THE SCAR LINE WHICH WAS MILDLY TENDER TO TOUCH AND CONSISTENT IN LOCATION WITH THE LOOP IN THE SCS LEADS WAS DUE TO LEAD MIGRATION WHICH WAS ONE OF THE REASON FOR REVISION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-2208-50, SERIAL #: (B)(4), DESCRIPTION: ST LINEAR LEAD 50CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO GET MORE COVERAGE. DURING THE REVISION, THE LEADS WERE REPLACED. NO DEVICE MALFUNCTION WAS SUSPECTED, AND IT WAS JUST LEAD MIGRATION. THE PATIENT WAS GETTING COVERAGE POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER COURSE OF ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A MILDLY TENDER TO TOUCH AND FIRM MIDLINE INCISION SITE. THE LOCATION WAS CONSISTENT WHERE THE SCS LEADS LOOPS AS CONFIRMED BY X-RAY. THE PATIENT WILL UNDERGO A LEAD REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A MILDLY TENDER TO TOUCH AND FIRM MIDLINE INCISION SITE. THE LOCATION WAS CONSISTENT WHERE THE SCS LEADS LOOPS AS CONFIRMED BY X-RAY. THE PATIENT WILL UNDERGO A LEAD REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A MILDLY TENDER TO TOUCH AND FIRM MIDLINE INCISION SITE. THE LOCATION WAS CONSISTENT WHERE THE SCS LEADS LOOPS AS CONFIRMED BY X-RAY. THE PATIENT WILL UNDERGO A LEAD REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A MILDLY TENDER TO TOUCH AND FIRM MIDLINE INCISION SITE. THE LOCATION WAS CONSISTENT WHERE THE SCS LEADS LOOPS AS CONFIRMED BY X-RAY. THE PATIENT WILL UNDERGO A LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608241 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2208-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention