BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 19013777 · Received April 1, 2024

    Report

    Report Number
    3006630150-2024-01976
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    August 25, 2023
    Report Date
    May 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: 7130101 / 7130266.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AT THE INCISION SITES FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT WAS PRESCRIBED PAIN MEDICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AT THE INCISION SITES FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT WAS PRESCRIBED PAIN MEDICATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT LOST COVERAGE AND ALSO EXPERIENCED UNCOMFORTABLE AND INADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE RIGHT LEAD WAS REPLACED AND PLACEMENT WAS ADJUSTED TO RECOVER COVERAGE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED LEAD WAS DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589444 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1416 212632 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention