BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11179234 · Received January 15, 2021

    Report

    Report Number
    3006630150-2020-06695
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    December 28, 2020
    Report Date
    January 15, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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-2218-70, SERIAL: (B)(4), BATCH: 7070970/7071667.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS POCKET SITE HAD OPENED AND THE IPG WAS EXPOSED. THE PHYSICIAN BELIEVED IT WAS NOT PROCEDURE OR DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO POSSIBLE INFECTION. THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS. ALL DEVICE COMPONENTS EXPLANTED AND DISCARDED. THE PATIENT REPORTEDLY DOING FINE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75781 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 364040 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1