BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3061818 · Received April 16, 2013

    Report

    Report Number
    3006630150-2013-00732
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S POCKET PAIN WAS BELIEVED TO BE DEVICE AND PROCEDURE RELATED. THE PATIENT WAS ALSO SKINNY, AND THE IPG WAS INITIALLY PLACED TOO HIGH AT THE RIGHT FLANK AND WAS RUBBING ON THE LOWER RIBS. THE IPG WAS RELOCATED TO THE RIGHT ABDOMEN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2012.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IMPLANT SITE WAS PAINFUL AND IT SHOOTS DOWN HER LOWER BACK. THE PATIENT UNDERWENT A POCKET REVISION WHEREIN THE POCKET WAS RELOCATED AND EXTENSIONS WERE ADDED. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IMPLANT SITE WAS PAINFUL AND IT SHOOTS DOWN HER LOWER BACK. THE PATIENT UNDERWENT A POCKET REVISION WHEREIN THE POCKET WAS RELOCATED AND EXTENSIONS WERE ADDED. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162663 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention