BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2192014 · Received August 4, 2011

    Report

    Report Number
    3006630150-2011-01248
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING FINE AFTER THE REVISION PROCEDURE. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN FOR EVALUATION AS THEY WAS DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE IPG FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION RECORDS OF THE IPG FOUND IT TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN IPG REPLACEMENT AFTER AN NON-DEVICE RELATED FALL ON THE IPG. THE PATIENT REPORTED THAT HE WAS UNABLE TO CHARGE HIS IPG AFTER THE FALL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN IPG REPLACEMENT AFTER AN NON-DEVICE RELATED FALL ON THE IPG. THE PATIENT REPORTED THAT HE WAS UNABLE TO CHARGE HIS IPG AFTER THE FALL.

    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 40 YR Required Intervention