BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2120659 · Received June 10, 2011

    Report

    Report Number
    3006630150-2011-00889
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A POCKET REVISION DURING WHICH THE PHYSICIAN ELECTED TO REPLACE THE IPG, NO MALFUNCTION WAS SUSPECTED. THE EXPLANTED IPG WILL NOT BE RETURNED TO BSN FOR FURTHER EVALUATION AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS HAVING TROUBLE CHARGING THEIR IMPLANT. THE PHYSICIAN WANTS TO REVISE THE PATIENT'S POCKET SITE AS HE BELIEVES THE IMPLANT IS IMPLANTED TOO DEEPLY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS HAVING TROUBLE CHARGING THEIR IMPLANT. THE PHYSICIAN WANTS TO REVISE THE PATIENT'S POCKET SITE AS HE BELIEVES THE IMPLANT IS IMPLANTED TOO DEEPLY.

    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 62 YR Required Intervention