BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2170641 · Received July 21, 2011

    Report

    Report Number
    3006630150-2011-01108
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    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 THE POCKET REVISION. DURING THE REVISION THE PHYSICIAN NOTED MOISTURE INSIDE OF THE IPG HEADER AND THE IPG WAS REPLACED. THE PATIENT IS DOING WELL FOLLOWING THE REVISION. THE EXPLANTED IPG WILL NOT BE RETURNED TO BSN FOR FURTHER EVALUATION AS IT WAS DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE IPG 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 IS EXPERIENCING A SHOCKING SENSATION AT THE POCKET SITE FOLLOWING NON-DEVICE RELATED WEIGHT LOSS. THE PATIENT WAS UNSUCCESSFULLY REPROGRAMMED AND WILL BE REVISED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING A SHOCKING SENSATION AT THE POCKET SITE FOLLOWING NON-DEVICE RELATED WEIGHT LOSS. THE PATIENT WAS UNSUCCESSFULLY REPROGRAMMED AND WILL BE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention