BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION SPECTRA

    MDR report key: 6081194 · Received November 7, 2016

    Report

    Report Number
    3006630150-2016-03190
    Event Type
    Death
    Date Received
    November 7, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 18, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8352-70 SERIAL # (B)(4) DESCRIPTION: COVEREDGE¿ X 32, 70 CM 4X8 SURGICAL LEAD 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY FOLLOWING THEIR PERMANENT IMPLANT PROCEDURE. THE REASON FOR THE PATIENT'S DEATH IS UNKNOWN. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734262 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death