BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 16212297 · Received January 19, 2023

    Report

    Report Number
    3006630150-2023-00142
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    January 9, 2023
    Report Date
    January 19, 2023
    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: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7072079. BRAND NAME: LINEAR 3-6, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7071872.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NO LONGER RECEIVING ADEQUATE PAIN COVERAGE, AND HE WAS ALSO EXPERIENCING PAIN AT THE SPINAL CORD STIMULATOR IMPLANTABLE PULSE GENERATOR, IPG SITE. THE PAIN AT THE POCKET SITE ALSO RADIATED AROUND TO THE PATIENTS SIDE. THE DEVICE WAS REPROGRAMMED, HOWEVER, THE ISSUE DID NOT RESOLVE. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE IPG AND LEADS WERE EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY. THE PATIENT WAS DOING FINE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113684 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 210674 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention