BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 8266923 · Received January 22, 2019

    Report

    Report Number
    3006630150-2019-00141
    Event Type
    Injury
    Date Received
    January 22, 2019
    Date of Event
    January 3, 2019
    Report Date
    April 8, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS WOUND DID NOT HEAL FOLLOWING A PROCEDURE WHEREIN MULTIPLE INFECTIOUS FLUID WERE WASHED OUT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN EVERYTHING WERE REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. MODEL NUMBER/CATALOG NUMBER: SC-8416-70 SERIAL NUMBER: (B)(4) BATCH/LOT NUMBER: 7023808 MODEL/CATALOG DESCRIPTION: ARTISAN MRI PADDLE LEAD 70 CM

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT PATIENT DEVELOPED AN INFECTION AT THE POCKET SITE. SIGN OF OOZING AT THE WOUND SITE WAS NOTED. THE PHYSICIAN BELIEVED IT WAS NOT DEVICE OR PROCEDURE RELATED AND PATIENTS WEIGHT AND BEING DIABETIC COULD HAVE ADDED TO THE INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE INFECTIOUS FLUID WERE WASHED OUT. THERE WILL BE NO FURTHER COURSE OF ACTION. THE PATIENT WAS DOING WELL.

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT DEVELOPED AN INFECTION AT THE POCKET SITE. SIGN OF OOZING AT THE WOUND SITE WAS NOTED. THE PHYSICIAN BELIEVED IT WAS NOT DEVICE OR PROCEDURE RELATED AND PATIENT'S WEIGHT AND BEING DIABETIC COULD HAVE ADDED TO THE INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE INFECTIOUS FLUID WERE WASHED OUT. THERE WILL BE NO FURTHER COURSE OF ACTION. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60742 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 354496 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention