BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3902991 · Received June 30, 2014

    Report

    Report Number
    3006630150-2014-01493
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    January 14, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE SUTURE CAME OUT OF THE SKIN AS NORMAL SUTURE WOULD STICK OUT. THERE IS NOTHING STICKING OUT ANY LONGER.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A NON-DEVICE RELATED WEIGHT LOSS AND THE SUTURE AT THE POCKET SITE HAD POKED THROUGH HER SKIN AS THE SKIN WAS THIN. THE PATIENT HAD IT STITCHED BACK UP.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A NON-DEVICE RELATED WEIGHT LOSS AND THE SUTURE AT THE POCKET SITE HAD POKED THROUGH HER SKIN AS THE SKIN WAS THIN. THE PATIENT HAD IT STITCHED BACK UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379781 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention