BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2991080 · Received March 6, 2013

    Report

    Report Number
    3006630150-2013-00357
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8216-50 SERIAL/LOT #: (B)(4) DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD BEEN CLEARED OF HER INFECTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO A PROCEDURE RELATED INFECTION AT THE POCKET SITE. THE PATIENT'S SYMPTOMS INCLUDED PUS AND PAIN AT THE POCKET SITE, DRAINAGE, AND REDNESS. MEDICAL TREATMENT WAS PROVIDED PRIOR TO EXPLANT, IV ANTIBIOTICS WERE GIVEN INTRAOPERATIVELY, AND FLUSHING AT THE POCKET SITE WAS ALSO DONE. THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC LINE).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO A PROCEDURE RELATED INFECTION AT THE POCKET SITE. THE PATIENT'S SYMPTOMS INCLUDED PUS AND PAIN AT THE POCKET SITE, DRAINAGE, AND REDNESS. MEDICAL TREATMENT WAS PROVIDED PRIOR TO EXPLANT, IV ANTIBIOTICS WERE GIVEN INTRAOPERATIVELY, AND FLUSHING AT THE POCKET SITE WAS ALSO DONE. THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC LINE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95880 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R