BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 7493090 · Received May 7, 2018

    Report

    Report Number
    3006630150-2018-01588
    Event Type
    Injury
    Date Received
    May 7, 2018
    Date of Event
    March 13, 2018
    Report Date
    May 24, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING HEADACHE DUE TO DURA PUNCTURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE REVISION PROCEDURE, THE PATIENT HAD A DURA PUNCTURE WHILE PLACING THE LEAD AND THEN UNDERWENT AN EXPLANT PROCEDURE INSTEAD. SYMPTOMS OF DURA PUNCTURE WERE UNKNOWN. THE PATIENT WAS PRESCRIBED FLORINEF AND WAS REPORTEDLY DOING WELL. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE REVISION PROCEDURE, THE PATIENT HAD A DURA PUNCTURE WHILE PLACING THE LEAD AND THEN UNDERWENT AN EXPLANT PROCEDURE INSTEAD. SYMPTOMS OF DURA PUNCTURE WERE UNKNOWN. THE PATIENT WAS PRESCRIBED FLORINEF AND WAS REPORTEDLY DOING WELL. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332813 PRECISION MONTAGE MRI SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 NA 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention