BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3011605 · Received March 19, 2013

    Report

    Report Number
    3006630150-2013-00474
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 24, 2013
    Report Date
    February 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT EXPLANT PROCEDURE DUE TO LUMP AT THE MIDLINE INCISION. THE PATIENT'S SYMPTOMS WERE FEVER AND CHILLS. THE PATIENT WAS ADMITTED TO THE ICU AND ANTIBIOTICS WERE GIVEN. INFECTION WAS CONFIRMED AND BELIEVED TO BE PROCEDURE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT EXPLANT PROCEDURE DUE TO LUMP AT THE MIDLINE INCISION. THE PATIENT'S SYMPTOMS WERE FEVER AND CHILLS. THE PATIENT WAS ADMITTED TO THE ICU AND ANTIBIOTICS WERE GIVEN. INFECTION WAS CONFIRMED AND BELIEVED TO BE PROCEDURE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT EXPLANT PROCEDURE DUE TO LUMP AT THE MIDLINE INCISION. THE PATIENT'S SYMPTOMS WERE FEVER AND CHILLS. THE PATIENT WAS ADMITTED TO THE ICU AND ANTIBIOTICS WERE GIVEN. INFECTION WAS CONFIRMED AND BELIEVED TO BE PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113606 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention