BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1870260 · Received October 11, 2010

    Report

    Report Number
    3006630150-2010-01733
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A NON-DEVICE RELATED BACK SURGERY A NON-BSN PHYSICIAN EXPLANTED THE PATIENT'S PRECISION SYSTEM. THE EXPLANTING PHYSICIAN REPORTED THAT THE LEAD WAS FRAYED AND THE WIRES WERE EXPOSED. 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-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SERIAL # (B)(4)| SERIAL # (B)(4)| MODEL # SC-1110-02| MODEL # SC-2218-50| IPG KIT (WITHOUT PULL - THROUGH TUNNELER):| ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET