BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1940860 · Received December 23, 2010

    Report

    Report Number
    3006630150-2010-02220
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    November 11, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION. TWO LEAD EXTENSIONS WERE ADDED TO GIVE MORE SLACK TO THE IPG. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS EXPERIENCING TUGGING AND PULLING OF HIS IPG CAUSING POCKET SITE PAIN. THE PT REPORTED HE IS ALSO HAVING TROUBLE LEANING AND LYING DOWN ON THE POCKET SITE. THE PT IS GETTING GOOD PAIN COVERAGE. AN X-RAY CONFIRMED SLIGHT MIGRATION OF THE RIGHT LEAD. THE PT WILL BE REVISED BUT THE PROCEDURE HAS NOT BEEN SCHEDULED.

    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 52 YR Male Required Intervention