BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 18782462 · Received February 26, 2024

    Report

    Report Number
    3006630150-2024-00972
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    November 15, 2023
    Report Date
    February 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT BRAND NAME: LINEAR 3-6 UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6. BATCH: 7076727, 7076735, 7076694, 7076672. BRAND NAME: COVEREDGE 32 UPN: M365SC8336700 MODEL: SC-8336-70 SERIAL: (B)(6). BATCH: 7071239.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD NEVER EXPERIENCED ANY PAIN RELIEF FROM THE SPINAL CORD STIMULATION (SCS) SYSTEM. THE SYSTEM WAS REPROGRAMMED HOWEVER THE EVENT DID NOT RESOLVE. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT WAS STABLE POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000854 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 213189 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention