BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17733921 · Received September 12, 2023

    Report

    Report Number
    3006630150-2023-05510
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    May 28, 2023
    Report Date
    September 12, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A FEW MONTHS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS . UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7114744/7116088 . PRODUCT FAMILY: SCS-LINEAR LEADS . UPN: M365SC2218700. MODEL: SC-2218-70 . SERIAL: (B)(6). BATCH: 7070939/7074539.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS BATTERY POCKET OPENED UP FOLLOWING A FALL. ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145552 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 563245 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention