BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2033583 · Received March 30, 2011

    Report

    Report Number
    3006630150-2011-00435
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION, THE PHYSICIAN REPLACED THE IPG DUE TO IT NOT BEING CHARGED AND BECAUSE HE NOTICED BLOOD IN THE IPG HEADER. THE DEVICE WAS WORKING PROPERLY AND THE PHYSICIAN DID NOT SUSPECTED AN IPG MALFUNCTION. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION, THE PHYSICIAN REPLACED THE IPG DUE TO IT NOT BEING CHARGED AND BECAUSE HE NOTICED BLOOD IN THE IPG HEADER. THE DEVICE WAS WORKING PROPERLY AND THE PHYSICIAN DID NOT SUSPECTED AN IPG MALFUNCTION. 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-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention