BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3813369 · Received May 15, 2014

    Report

    Report Number
    3006630150-2014-01067
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRIOR TO THE REVISION PROCEDURE, THE PATIENT STATED THAT THE IMPLANT WAS VERY SUPERFICIAL AND BARELY UNDER THE SKIN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD EXPERIENCED POCKET SITE PAIN AND UNDERWENT A POCKET REVISION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD EXPERIENCED POCKET SITE PAIN AND UNDERWENT A POCKET REVISION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290054 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention