BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION SPECTRA®

    MDR report key: 5668534 · Received May 19, 2016

    Report

    Report Number
    3006630150-2016-01175
    Event Type
    Death
    Date Received
    May 19, 2016
    Date of Event
    April 18, 2016
    Report Date
    April 22, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-8216-50, SERIAL/LOT: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY. NO FURTHER DETAILS WERE PROVIDED. THE PHYSICIAN INDICATED THAT HE HAD NOT SEEN THE PATIENT SINCE SHE WAS IMPLANTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY. NO FURTHER DETAILS WERE PROVIDED. THE PHYSICIAN INDICATED THAT HE HAD NOT SEEN THE PATIENT SINCE SHE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322469 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death