BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 6478525 · Received April 10, 2017

    Report

    Report Number
    3006630150-2017-01287
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    March 20, 2017
    Report Date
    March 20, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT EVERY PART OF THE OLD LEAD WAS EXPLANTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD DID NOT APPEAR TO BE DAMAGED BEFORE SURGERY. SC-2408-56 (SN (B)(4)): DEVICE EVALUATION INDICATED THAT THE LEAD COMPLAINT HAS BEEN CONFIRMED. VISUAL INSPECTION FOUND THAT ELECTRODE # 2 ON THE DISTAL END WAS MISSING. ALSO VISUAL INSPECTION REVEALED THAT THE DISTAL END ELECTRODE #7 WAS SCRATCHED. REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES WHEN THE LEAD WAS MANUFACTURED. THE CAUSE OF THE LEAD DAMAGE COULDN'T BE DETERMINED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE ONE OF THE PATIENT¿S LEAD APPEARED DAMAGED UPON EXAMINATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE ONE OF THE PATIENT¿S LEAD APPEARED DAMAGED UPON EXAMINATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE ONE OF THE PATIENT¿S LEAD APPEARED DAMAGED UPON EXAMINATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260308 PRECISION MONTAGE MRI SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 NA 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR