BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10381328 · Received August 7, 2020

    Report

    Report Number
    3006630150-2020-03308
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    July 17, 2020
    Report Date
    August 7, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC8216700, MODEL: SC-8216-70, SERIAL: (B)(4), BATCH: 7070181.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG AND LEAD SITE. SYMPTOMS OF FEVER AND PAIN WAS NOTED. THE PHYSICIAN BELIEVED THAT IT WAS NOT DEVICE RELATED BUT RATHER PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS PRIOR THE PROCEDURE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL COMPONENTS WERE REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846008 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 366817 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention