BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 12724221 · Received October 29, 2021

    Report

    Report Number
    3006630150-2021-06088
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    September 7, 2021
    Report Date
    November 22, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR EXPLANT WAS DUE TO THE PATIENT NOT GETTING PAIN RELIEF.

    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-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH:7073230 / 7080118.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617152 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 505476 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention