BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2963457 · Received February 15, 2013

    Report

    Report Number
    3006630150-2013-00232
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-1110-02, SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG) MODEL #: SC-2218-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM 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 NOT PROCEDURE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE MIDLINE INCISION SITE WHICH WAS NOT DEVICE RELATED. SYMPTOM INCLUDES REDNESS AT THE SITE. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS BUT THIS DID NOT RESOLVE THE INFECTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE MIDLINE INCISION SITE WHICH WAS NOT DEVICE RELATED. SYMPTOM INCLUDES REDNESS AT THE SITE. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS BUT THIS DID NOT RESOLVE THE INFECTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69242 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention