BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME 16

    MDR report key: 21964878 · Received May 5, 2025

    Report

    Report Number
    3006630150-2025-03063
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    January 1, 2020
    Report Date
    April 22, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2020. BLOCK D6B: EXPLANT DATE: 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7121437. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCKS B5 AND H6. BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2020. BLOCK D6B: EXPLANT DATE: 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT EXPLANT PROCEDURE DUE THE DEVICE STICKING OUT OF PATIENTS BACK. BURNING SENSATION WAS ALSO NOTED. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION AND NOTED THAT THE DEVICE WAS STICKING OUT OF THE BACK. THE PATIENT UNDERWENT AND EXPLANT PROCEDURE. NO FURTHER INFORMATION CAN BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407901 WAVEWRITER ALPHA? PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 207845 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1