BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 15740153 · Received November 4, 2022

    Report

    Report Number
    3006630150-2022-06023
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    August 7, 2022
    Report Date
    November 30, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 7091679/7091849.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN AT THE IPG SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE IPG AND THE LINEAR LEADS WERE EXPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN AT THE IPG SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE IPG AND THE LINEAR LEADS WERE EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159354 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 506956 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention