BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3203436 · Received July 2, 2013

    Report

    Report Number
    3006630150-2013-01375
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    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 INFORMATION WAS RECEIVED THAT THE REASON FOR REVISION WAS DUE TO INEFFECTIVE THERAPY. THE PHYSICIAN CHOSE TO REPLACE THE SYSTEM. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE. 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-8120-50, SERIAL/LOT #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE PATIENT'S REVISION, IT WAS FOUND OUT THAT THE LEAD WAS FRACTURED. ACCORDING TO THE PHYSICIAN, THE LEAD WAS FRACTURED PRIOR TO THE REVISION. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A REVISION PROCEDURE FOR UNKNOWN REASON.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A REVISION PROCEDURE FOR UNKNOWN REASON.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A REVISION PROCEDURE FOR UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301280 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention