BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10113901 · Received June 3, 2020

    Report

    Report Number
    3006630150-2020-02307
    Event Type
    Injury
    Date Received
    June 3, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7071061 / 7071174. THE DEVICES WERE NOT RETURNED FOR A TECHNICAL ANALYSIS AND THE INVESTIGATION DID NOT REVEAL ANY POTENTIAL MANUFACTURING ISSUES, THEREFORE, THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN AT THE POCKET SITE DUE TO INFECTION. THE CAUSE OF INFECTION WAS NOT KNOWN, AND THE PHYSICIAN REPORTED THAT NOTHING HAPPEND DURING THE IPG IMPLANT PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT UNDERWENT AND EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.THE IPG AND LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579508 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 367268 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention