BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3854044 · Received June 6, 2014

    Report

    Report Number
    3006630150-2014-01264
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD FRACTURE HAPPENED DURING EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    SC-2218-50 SN (B)(4): DEVICE EVALUATION INDICATED THAT THE LEAD WAS CUT APPROXIMATELY 27 CM FROM THE DISTAL END. X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE FRACTURED AT THE BENT/KINKED LOCATION 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. SC-2218-50 SN (B)(4): DEVICE EVALUATION INDICATED THAT THE LEAD WAS CUT APPROXIMATELY 22 CM FROM THE DISTAL END. X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE FRACTURED AT THE BENT/KINKED LOCATION 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INEFFECTIVE THERAPY. DURING DEVICE ANALYSIS, FRACTURE ON MULTIPLE CABLES WERE NOTED ON THE LEADS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INEFFECTIVE THERAPY. DURING DEVICE ANALYSIS, FRACTURE ON MULTIPLE CABLES WERE NOTED ON THE LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332090 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR