BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 12031088 · Received June 21, 2021

    Report

    Report Number
    3006630150-2021-03078
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    May 31, 2021
    Report Date
    June 21, 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

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216700, MODEL: SC-8216-70, SERIAL: (B)(4), BATCH: 272693 / 273524. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(4), BATCH: 7070737 / 7070766.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS PREVIOUS POCKET SITE (MFR. REPORT NUMBER: 3006630150-2021-00901) HAD AN INFECTION AND THE PATIENT WAS PUT ON ANTIBIOTICS WITH NO SUCCESS. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT DEVICE RELATED. ALL DEVICE COMPONENTS WERE EXPLANTED EXCEPT FOR THE IPG THAT REMAINED IN THE NEW POCKET SITE. THE PATIENT WAS DOING WELL POST-OPERATIVELY AND EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932729 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 355846 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention