BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 6350449 · Received February 22, 2017

    Report

    Report Number
    3006630150-2017-00515
    Event Type
    Injury
    Date Received
    February 22, 2017
    Date of Event
    January 31, 2017
    Report Date
    January 31, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-4316, SERIAL #: (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE. MODEL #: SC-8336-50, LOT #: 1091949, DESCRIPTION: COVEREDGE 32, 50 CM 4X8 SURGICAL LEAD. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD INFECTION AT THE IPG SITE. SYMPTOMS WERE SLIGHT FEVER, REDDISH AND INFLAMED AT THE POCKET SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132806 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention