BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2222063 · Received August 24, 2011

    Report

    Report Number
    3006630150-2011-01314
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. DURING THE REVISION THE PHYSICIAN NOTED THAT HE BELIEVES THE BATTERY DEPLETION MAYBE A RESULT OF THE EXTENSIONS NOT BEING TIGHTENED DOWN. A NEW IPG AND NEW EXTENSIONS WERE IMPLANTED. THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG IS DEPLETING QUICKLY. A BSN REPRESENTATIVE ANALYZED THE PATIENTS DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE PHYSICIAN WILL REPLACE THE PATIENT'S IPG.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG IS DEPLETING QUICKLY. A BSN REPRESENTATIVE ANALYZED THE PATIENTS DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE PHYSICIAN WILL REPLACE THE PATIENT'S IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention