BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 4295738 · Received December 3, 2014

    Report

    Report Number
    3006630150-2014-02818
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    November 10, 2014
    Report Date
    November 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS CONFIRMED THE COMPLAINT. LEAD SC-8216-50 (SN (B)(4))- VISUAL INSPECTION FOUND A SETSCREW MARK LOCATED BETWEEN THE EDGE OF RETENTION SLEEVE AND CONTACT #8. THE SETSCREW MARK INDICATES THAT THE PROXIMAL END OF THE PADDLE LEAD WAS NOT FULLY INSERTED INTO THE IPG HEADER. VISUAL AND X-RAY INSPECTION OF THE LEAD REVEALED THAT 4 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. NO CABLES ARE EXPOSED AT THE FRACTURE SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCES. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCES. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781472 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1