BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 17032526 · Received May 31, 2023

    Report

    Report Number
    3006630150-2023-03079
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    May 9, 2023
    Report Date
    July 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7122042/7122327.

    Additional Manufacturer Narrative · 0

    EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR EXPLANT WAS DUE TO HEMATOMA. ALL DEVICE COMPONENTS WERE EXPLANTED. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131076 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 561110 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention