BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2231602 · Received September 1, 2011

    Report

    Report Number
    3006630150-2011-01371
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2366-50 (B)(4): LINEAR 3-6 LEAD 50CM MODEL # SC-2218-50 (B)(4) DESCRIPTION: ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCH STYLET IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING NON-DEVICE RELATED WEIGHT LOSS, ONE OF THE PATIENT'S LEADS HAD ERODED THROUGH THE SKIN AND WAS EXPOSED. THE PHYSICIAN OPENED THE INCISION SITE, REMOVED THE SILK SUTURE THAT WAS CAUSING THE LEAD TO PROTRUDE, AND BURIED THE LEADS DEEPER. THE PATIENT WAS GIVEN IV ANTIBIOTICS AND WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R