BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION SPECTRA

    MDR report key: 6617112 · Received June 6, 2017

    Report

    Report Number
    3006630150-2017-01968
    Event Type
    Death
    Date Received
    June 6, 2017
    Date of Event
    May 7, 2017
    Report Date
    May 12, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO FURTHER INFORMATION COULD BE OBTAINED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-4318, LOT # 19258950, DESCRIPTION: CLIK X ANCHOR. MODEL # SC-8216-50, SERIAL # (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND WILL NOT BE RETURNED. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY THREE DAYS AFTER AN IMPLANT PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT CAME OUT OF THE ANESTHESIA ROUGH AND NEVER RECOVERED. THE PHYSICIAN DOES NOT KNOW IF THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY THREE DAYS AFTER AN IMPLANT PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT CAME OUT OF THE ANESTHESIA ROUGH AND NEVER RECOVERED. THE PHYSICIAN DOES NOT KNOW IF THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397336 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 Death