BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2240213 · Received September 9, 2011

    Report

    Report Number
    3006630150-2011-01433
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-1110-02, SERIAL#: (B)(4), MODEL DESCRIPTION:PRECISION IMPLANTABLE PULSE GENERATOR (IPG) MODEL#:SC-2218-50, SERIAL#: (B)(4) MODEL DESCRIPTION:LINEAR ST LEAD WITH PRELOADED ENHANCED STYLET - 50 CM EXPLANTED DEVICES WILL NOT BE RETURN TO BSN AS THEY WERE 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

    IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED DUE TO PARALYSIS IN HIS LEGS. ACCORDING TO THE PHYSICIAN, THE PARALYSIS IS NOT PRE-EXISTING AND IS UNLIKELY TO IMPROVE. THE PARALYSIS IS NOT DEVICE RELATED BUT PROCEDURE RELATED. THE PATIENT WAS ORIGINALLY IMPLANTED FOR FAILED BACK SURGERY SYNDROME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED DUE TO PARALYSIS IN HIS LEGS. ACCORDING TO THE PHYSICIAN THE PARALYSIS IS NOT PRE-EXISTING AND IS UNLIKELY TO IMPROVE. THE PARALYSIS IS NOT DEVICE RELATED BUT PROCEDURE RELATED. THE PATIENT WAS ORIGINALLY IMPLANTED FOR FAILED BACK SURGERY SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R