BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2202693 · Received August 11, 2011

    Report

    Report Number
    3006630150-2011-01213
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 24, 2011
    Report Date
    July 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED IPG FOUND 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 BECAUSE THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WOULD NOT CHARGE OUT OF HIBERNATION. THE PHYSICIAN DECIDED TO REVISE THE IPG. THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WOULD NOT CHARGE OUT OF HIBERNATION. THE PHYSICIAN DECIDED TO REVISE THE IPG. THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE REVISION PROCEDURE.

    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 61 YR Required Intervention