BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2843909 · Received November 23, 2012

    Report

    Report Number
    3006630150-2012-02178
    Event Type
    Injury
    Date Received
    November 23, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO INITIAL MDR: ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2366-50, SERIAL #S (B)(4), DESCRIPTION: LINEAR 3-6 LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INTERNAL STITCH FESTERING AT THE LEAD SITE THAT PREVENTED THE WOUND FROM HEALING. THE PATIENT UNDERWENT A LEAD REVISION, DURING WHICH, THE PHYSICIAN OPENED THE WOUND AND CUT OUT THE INTERNAL STITCH. THE WOUND WAS CLEANED, IRRIGATED AND CLOSED. THE PATIENT WAS ADMINISTERED ORAL ANTIBIOTICS. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE AND THE WOUND HAS HEALED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INTERNAL STITCH FESTERING AT THE LEAD SITE THAT PREVENTED THE WOUND FROM HEALING. THE PATIENT UNDERWENT A LEAD REVISION, DURING WHICH, THE PHYSICIAN OPENED THE WOUND AND CUT OUT THE INTERNAL STITCH. THE WOUND WAS CLEANED, IRRIGATED AND CLOSED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE AND THE WOUND HAS HEALED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention