BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2834208 · Received November 15, 2012

    Report

    Report Number
    3006630150-2012-02109
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE LEAD (SC-8216-50/SN#(B)(4)) PASSED MECHANICAL TEST. THE COMPLAINT HAS BEEN CONFIRMED. VISUAL INSPECTION REVEALED THAT THREE OF THE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD, 1 CM FROM THE CLIK ANCHOR SET SCREW MARK. ADDITIONALLY, THERE ARE MINOR BURN MARKS ON THE INSULATION OF THE LEAD. THE DAMAGE TO THE CABLES IS CONSISTENT WITH FRACTURES CAUSED WHEN A LEAD IS SUTURED WITHOUT THE USE OF A SUTURE SLEEVE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE LEAD (B)(4) PASSED VISUAL, ELECTRICAL, MECHANICAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. DEVICE EVALUATION INDICATED THAT THE LEAD (B)(4) PASSED LEAD DIMENSIONAL TEST, DIAMETER AND LEAD ELECTRODE PITCH TEST. THE COMPLAINT HAS BEEN CONFIRMED. VISUAL INSPECTION REVEALED THAT THREE OF THE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD, 1 CM FROM THE CLIK ANCHOR SET SCREW MARK. ADDITIONALLY, THERE ARE MINOR BURN MARKS ON THE INSULATION OF THE LEAD. THE DAMAGE TO THE CABLES IS CONSISTENT WITH FRACTURES CAUSED WHEN A LEAD IS SUTURED WITHOUT THE USE OF A SUTURE SLEEVE. DEVICE EVALUATION INDICATED THAT THE CLIK ANCHOR PASSED VISUAL, AND PHOTOGRAPHIC IMAGING TESTS PERFORMED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD CONTACTS WITH HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION AND THE LEAD WAS REPLACED WITH A NEW ONE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD CONTACTS WITH HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION AND THE LEAD WAS REPLACED WITH A NEW ONE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD CONTACTS WITH HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION AND THE LEAD WAS REPLACED WITH A NEW ONE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR