BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3903029 · Received June 30, 2014

    Report

    Report Number
    3006630150-2014-01476
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2316-70, SERIAL #: (B)(4), DESCRIPTION: INFINION 70 CM LEAD KIT. MODEL #: SC-3400-30, SERIAL #: (B)(4), DESCRIPTION: INFINION SPLITTER 2X8 KIT (30 CM). THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING STIMULATION AND THE RIGHT LEAD WAS SHOWING HIGH IMPEDANCES. DATABASE ANALYSIS REVEALED HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE, DURING WHICH, THE PHYSICIAN DETERMINED THAT THE LEAD WAS COMPLETELY BENT IN HALF AND SUTURE WAS MISSING WHICH CAUSED THE HIGH IMPEDANCES. THE LEAD WAS REPLACED AND THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381082 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention