BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION MONTAGE

    MDR report key: 6770680 · Received August 7, 2017

    Report

    Report Number
    3006630150-2017-02727
    Event Type
    Death
    Date Received
    August 7, 2017
    Date of Event
    July 8, 2017
    Report Date
    November 17, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    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 THAT NO FURTHER INFORMATION COULD BE OBTAINED. 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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2408-56 SERIAL (B)(4) DESCRIPTION: AVISTA MRI PERC LEAD KIT, 56 CM MODEL # SC-4319 LOT # 20629356 DESCRIPTION: CLIK X MRI ANCHOR.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN SUSPECTING THAT CAUSE OF DEATH WAS DUE TO AN OVERDOSE OF MEDICATION RESULTING IN A CARDIAC ISSUE. IT WAS NOT DEVICE RELATED NOR PROCEDURE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY. IT IS UNKNOWN IF THE EVENT WAS DUE TO THE PROCEDURE OR DEVICE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY. IT IS UNKNOWN IF THE EVENT WAS DUE TO THE PROCEDURE OR DEVICE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY. IT IS UNKNOWN IF THE EVENT WAS DUE TO THE PROCEDURE OR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551381 PRECISION MONTAGE SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 NA 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death