BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18988636 · Received March 27, 2024

    Report

    Report Number
    3006630150-2024-01834
    Event Type
    Injury
    Date Received
    March 27, 2024
    Date of Event
    October 1, 2021
    Report Date
    March 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED AROUND A MONTH AFTER IMPLANT. BLOCK D6B: EXPLANT DATE: AROUND A MONTH AFTER IMPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336700. MODEL: SC-8336-70. SERIAL: (B)(6). BATCH: 7071622. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 26689986.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED STAPHYLOCOCCAL INFECTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND REPORTEDLY DOING WELL. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493504 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 519189 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention