BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 12332671 · Received August 17, 2021

    Report

    Report Number
    3006630150-2021-04557
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    March 15, 2020
    Report Date
    October 5, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336700. MODEL: SC-8336-70. SERIAL: (B)(6). BATCH: 7023864.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR EXPLANT WAS DUE TO SCS (SPINAL CORD STIMULATOR) WAS NOT HELPING WITH PAIN. THE EXPLANTED IPG AND LEAD WERE DISCARDED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED MIDDLE OF (B)(6) 2020. EXPLANT DATE: MIDDLE OF (B)(6) 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227648 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 348351 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention