BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3831599 · Received May 26, 2014

    Report

    Report Number
    3006630150-2014-01181
    Event Type
    Injury
    Date Received
    May 26, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 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

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DRAINAGE IN THE POCKET SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS EXPLANTED AND A NEW POCKET SITE WAS CREATED FOR THE REPLACEMENT IPG. THE PHYSICIAN IRRIGATED THE POCKET SITE AND VANCOMYCIN POWDER WAS ADMINISTERED TO THE WOUND. THE PHYSICIAN DID NOT SUSPECT INFECTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309942 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention