BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1347114 · Received March 20, 2009

    Report

    Report Number
    2029203-2009-00696
    Event Type
    Injury
    Date Received
    March 20, 2009
    Date of Event
    February 20, 2009
    Report Date
    February 20, 2009
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PT WAS EXPERIENCING POCKET PAIN WHILE CHARGING. THE PT MET WITH HIS PHYSICIAN WHO ADMINISTERED TRIGGER POINT INJECTIONS TO TREAT THE PAIN. THE PT WAS REPROGRAMMED AND IS REPORTEDLY DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention