BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3090745 · Received May 2, 2013

    Report

    Report Number
    3006630150-2013-00856
    Event Type
    Injury
    Date Received
    May 2, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 2013. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-1110-02, SERIAL/LOT #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG). 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'S INFECTION WAS RESOLVED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT HAD AN INFECTION AT THE THORACIC INCISION AND SUPERFICIALLY AT THE LEAD SITE. PATIENT'S SYMPTOMS WERE PAIN, GENERAL MALAISE AND DRAINING PUS. THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. INTRAVENOUS ANTIBIOTICS WERE GIVEN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. THE PATIENT IS STILL RECOVERING WITH INTRAVENOUS ANTIBIOTICS THERAPY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT HAD AN INFECTION AT THE THORACIC INCISION AND SUPERFICIALLY AT THE LEAD SITE. PATIENT¿S SYMPTOMS WERE PAIN, GENERAL MALAISE AND DRAINING PUS. THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. INTRAVENOUS ANTIBIOTICS WERE GIVEN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. THE PATIENT IS STILL RECOVERING WITH INTRAVENOUS ANTIBIOTICS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191334 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention