BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION®

    MDR report key: 2794590 · Received October 17, 2012

    Report

    Report Number
    3006630150-2012-01892
    Event Type
    Death
    Date Received
    October 17, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2218-50, SERIAL # (B)(4). DESCRIPTION: ST LINEAR LEAD, 50CM, MODEL # SC-8216-50, SERIAL # (B)(4), DESCRIPTION: ARTISAN 16 CONTACT SURGICAL PADDLE LEAD, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT FELL ON HIS IPG AND IT CAUSED A POCKET OF FLUID TO FORM UNDERNEATH THE IPG. APPARENTLY THAT FLUID TURNED INTO AN INFECTION. THE PATIENT ALSO HAD INFECTIONS ON OTHER PLACES ON HIS BODY. WHEN IPG WAS FINALLY REMOVED THE INFECTION HAD SPREAD AND WENT SEPTIC INTO HIS BLOOD STREAM. THEY TRIED AGGRESSIVELY TO FIGHT THE INFECTION AND IT HAD GONE INTO HIS LUNGS. PATIENT WAS ON REALLY HIGH DOSES OF ANTIBIOTICS. IPG WAS IMPLANTED ON RIGHT HIP.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN INFECTION AROUND THE IPG SITE. THE PATIENT WAS GIVEN INTRAVENOUS ANTIBIOTICS. THE PATIENT DIED AS A RESULT OF THE INFECTION. THE PHYSICIAN DOES NOT BELIEVE THAT THE INFECTION AND DEATH WERE DEVICE OR PROCEDURE RELATED, BUT WAS CAUSED BY THE PATIENT'S PRE-EXISTING CONDITIONS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN INFECTION AROUND THE IPG SITE. THE PATIENT WAS GIVEN INTRAVENOUS ANTIBIOTICS. THE PATIENT DIED AS A RESULT OF THE INFECTION. THE PHYSICIAN DOES NOT BELIEVE THAT THE INFECTION AND DEATH WERE DEVICE OR PROCEDURE RELATED, BUT WAS CAUSED BY THE PATIENT'S PRE-EXISTING CONDITIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R