BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2221057 · Received August 23, 2011

    Report

    Report Number
    3006630150-2011-01296
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE AND THE IPG WAS MOVED TO A MORE COMFORTABLE LOCATION. THE PATIENT IS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS GAINED WEIGHT (NOT DEVICE RELATED) AND IS EXPERIENCING DIFFICULTY CHARGING HER IMPLANT. THE PATIENT WILL UNDERGO A POCKET REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS GAINED WEIGHT (NOT DEVICE RELATED) AND IS EXPERIENCING DIFFICULTY CHARGING HER IMPLANT. THE PATIENT WILL UNDERGO A POCKET REVISION PROCEDURE.

    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 82 YR Required Intervention