BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1970416 · Received January 17, 2011

    Report

    Report Number
    3006630150-2011-00066
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 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
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT UNDERWENT A POCKET REVISION BEACAUSE THERE WAS A BUBBLE OVER THE INCISION SITE. NO INFECTION HAS BEEN SUSPECTED. THE PHYSICIAN RELOCATED THE IPG SITE TO A NEW LOCATION AND THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PT UNDERWENT A POCKET REVISION BECAUSE THERE WAS A "BUBBLE" OVER THE INCISION SITE. NO INFECTION HAS BEEN SUSPECTED. THE PHYSICIAN RELOCATED THE IPG SITE TO A NEW LOCATION AND THE PT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    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 41 YR Required Intervention