BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 21531795 · Received March 5, 2025

    Report

    Report Number
    3006630150-2025-01254
    Event Type
    Injury
    Date Received
    March 5, 2025
    Date of Event
    February 10, 2025
    Report Date
    March 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN:M365SC2218500. MODEL:SC-2218-50. SERIAL:(B)(6)/(B)(6) . BATCH:7121632/7121092. PRODUCT FAMILY: SCS-LEAD FIXATION . UPN:M365SC43160. MODEL:SC-4316 . SERIAL: NA. BATCH:31040596.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE CAUSE OF INFECTION WAS UNKNOWN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED DEVICES WERE NOT RETURNED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434812 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 216470 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention