BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3211798 · Received July 8, 2013

    Report

    Report Number
    3006630150-2013-01402
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION AND WAS DOING WELL POST OPERATIVELY. 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-2218-50, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. SYMPTOMS INCLUDE WOUND THAT WAS NOT HEALING, DISCHARGE, REDNESS AND SORENESS AT THE SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS DUE TO THE PATIENT SWIMMING IN A PUBLIC POOL. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS. THE PATIENT¿S WOUND LOOKED BETTER.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. SYMPTOMS INCLUDE WOUND THAT WAS NOT HEALING, DISCHARGE, REDNESS AND SORENESS AT THE SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS DUE TO THE PATIENT SWIMMING IN A PUBLIC POOL. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS. THE PATIENT¿S WOUND LOOKED BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311277 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention