BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2931988 · Received January 28, 2013

    Report

    Report Number
    3006630150-2013-00157
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    September 10, 2012
    Report Date
    January 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE TO INITIAL MDR FIELD: ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE TWO LEADS DISPLAYING HIGH IMPEDANCES. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME REGARDING THE LEADS.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT HAS BEEN CONFIRMED FOR S/N (B)(4). VISUAL INSPECTION REVEALED THAT THE LEAD WAS CLEANLY CUT APPROXIMATELY 11 INCHES FROM THE DISTAL END. X-RAY INSPECTION OF THE LEAD REVEALED THAT ALL OF THE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE BENT/KINKED LOCATION IS 1 CM FROM THE SET SCREW MARK OF THE CLIK ANCHOR. IT APPEARS TO BE A RESULT OF FATIGUE. ELECTRICAL TESTS COULD NOT BE PERFORMED DUE TO BROKEN CABLES. THE COMPLAINT HAS BEEN CONFIRMED FOR S/N (B)(4). VISUAL INSPECTION REVEALED THAT THE LEAD WAS CLEANLY CUT APPROXIMATELY 14 INCHES FROM THE DISTAL END. X-RAY INSPECTION OF THE LEAD REVEALED THAT 2 CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE BENT/KINKED LOCATION IS 1 CM FROM THE SET SCREW MARK OF THE CLIK ANCHOR. IT APPEARS TO BE A RESULT OF FATIGUE. ELECTRICAL TESTS COULD NOT BE PERFORMED DUE TO BROKEN CABLES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: SC-2138-70 SERIAL/LOT#: (B)(4), DESCRIPTION: SCS 70CM III LEAD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. A SYSTEM CHECK REVEALED HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE PHYSICIAN CHOSE TO REPLACE THE LEAD. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. A SYSTEM CHECK REVEALED HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE PHYSICIAN CHOSE TO REPLACE THE LEAD. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. A SYSTEM CHECK REVEALED HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE PHYSICIAN CHOSE TO REPLACE THE LEAD. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. A SYSTEM CHECK REVEALED HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE PHYSICIAN CHOSE TO REPLACE THE LEAD. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37434 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2138-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1