BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 21307189 · Received February 4, 2025

    Report

    Report Number
    3006630150-2025-00419
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    January 3, 2025
    Report Date
    February 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: M365SC2218700; MODEL: SC-2218-70; SERIAL: (B)(6); BATCH: 7080461/7080377/7083808/7084068.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) SYSTEM EXPLANT PROCEDURE DUE TO THE IMPLANTABLE PULSE GENERATOR (IPG) THAT KEPT MOVING AND THE POCKET WOULD NOT HOLD THE IPG. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060762 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 203589 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention