BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION®

    MDR report key: 5653368 · Received May 13, 2016

    Report

    Report Number
    3006630150-2016-01240
    Event Type
    Death
    Date Received
    May 13, 2016
    Date of Event
    April 25, 2016
    Report Date
    April 25, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE INITIAL MDR IN FIELD SC-1110-02, S/N (B)(4) THERE IS NO REPORT OF IPG MALFUNCTION IN THE REPORTED COMPLAINT, ONLY THAT THE PATIENT EXPIRED AND THE SYSTEM WAS EXPLANTED. THE IPG EXHIBITS NORMAL DEVICE CHARACTERISTICS. SC-8216-50, S/N (B)(4) IT IS INDICATED THAT THE PADDLE LEAD 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

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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S DEVICE WAS RETURNED. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THE PATIENT RECENTLY PASSED AWAY. NO FURTHER INFORMATION COULD BE OBTAINED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S DEVICE WAS RETURNED. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THE PATIENT RECENTLY PASSED AWAY. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309807 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death