BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION MONTAGE

    MDR report key: 6754062 · Received July 31, 2017

    Report

    Report Number
    3006630150-2017-02637
    Event Type
    Death
    Date Received
    July 31, 2017
    Date of Event
    April 23, 2017
    Report Date
    April 26, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2408-56 SERIAL#: (B)(4) DESCRIPTION: AVISTA MRI PERC LEAD KIT, 56 CM 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S DEATH/SUICIDE WAS DUE TO NORMAL PAIN NOT DUE TO THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO A LEAD REVISION PROCEDURE TO IMPLANT ADDITIONAL LEADS. UPON FOLLOW-UP, IT WAS DISCOVERED THAT THE PATIENT COMMITTED SUICIDE. THE PHYSICIAN ASSESSED THAT THE SUICIDE WAS PAIN RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO A LEAD REVISION PROCEDURE TO IMPLANT ADDITIONAL LEADS. UPON FOLLOW-UP, IT WAS DISCOVERED THAT THE PATIENT COMMITTED SUICIDE. THE PHYSICIAN ASSESSED THAT THE SUICIDE WAS PAIN RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534798 PRECISION MONTAGE SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 NA 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 Death