BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 16599381 · Received March 23, 2023

    Report

    Report Number
    3006630150-2023-01495
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    September 22, 2022
    Report Date
    March 23, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED FALL OF LAST YEAR. EXPLANT DATE: SEPTEMBER 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: 7091633/7091845.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE AN UNKNOWN REASON. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355723 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1416 202397 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention