BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2230009 · Received August 31, 2011

    Report

    Report Number
    3006630150-2011-01333
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT CONTACT #12, WHICH WAS MISSING FORM THE LEAD WHEN IT WAS RETURNED TO BSN, WAS RETRIEVED AND NOT LEFT INSIDE THE PATIENT'S BODY.

    Additional Manufacturer Narrative · 1

    THE LEAD EXHIBITED NOT ONLY THE EXPLANT DAMAGES BUT ALSO PRE-EXPLANT DAMAGES. THE PHYSICIAN STATED THAT HE OBSERVED DAMAGES ON THE DISTAL END PORTION (FRAYING AND EXPOSED WIRES) AS HE PULLED THE LEAD OUT FROM THE PATIENT. THIS WAS CONFIRMED IN VISUAL INSPECTION. VISUAL INSPECTION ALSO FOUND E #12 IS MISSING FROM THE PADDLE THAT WAS USED AS CATHODE (B)(4). THESE FACTS SUGGEST THAT THE IMPLANTED PADDLE LEAD MAY HAVE BEEN DAMAGED PRIOR TO EXPLANT, WHICH IN TURN HAD CAUSED INTERMITTENT STIMULATION AS THE PATIENT'S POSTURE CHANGED. THE ROOT CAUSE OF THE DAMAGE CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION, THE PHYSICIAN DISCOVERED FRAYING AT THE DISTAL END OF THE PADDLE LEAD. IT APPEARED THAT TWO OF THE CABLES HAD BECOME EXPOSED AND WERE NO LONGER INSULATED. THE LEAD WAS REPLACED AND THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION, THE PHYSICIAN DISCOVERED FRAYING AT THE DISTAL END OF THE PADDLE LEAD. IT APPEARED THAT TWO OF THE CABLES HAD BECOME EXPOSED AND WERE NO LONGER INSULATED. THE LEAD WAS REPLACED AND THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION, THE PHYSICIAN DISCOVERED FRAYING AT THE DISTAL END OF THE PADDLE LEAD. IT APPEARED THAT TWO OF THE CABLES HAD BECOME EXPOSED AND WERE NO LONGER INSULATED. THE LEAD WAS REPLACED AND THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8116-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention