BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3791382 · Received May 5, 2014

    Report

    Report Number
    3006630150-2014-00963
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2218-50 SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM SC-2218-50 (SN (B)(4)). DEVICE EVALUATION INDICATED THAT ALL OF THE CABLES OF THE LEAD WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD, APPROXIMATELY 5.62 CM FROM THE PROXIMAL END. THIS LOCATION APPEARED TO BE THE SITE WHERE THE SUTURE SLEEVE WAS POSITIONED. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT OF HIGH IMPEDANCE. SC-2208-50 (SN (B)(4)) A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING STIMULATION. DATABASE ANALYSIS REVEALED HIGH IMPEDANCES ON SOME ELECTRODES AND SUGGESTED LEAD FRACTURE. THE PATIENT UNDERWENT LEAD REPLACEMENT AND WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267213 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2208-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention