BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 21225650 · Received January 23, 2025

    Report

    Report Number
    3006630150-2025-00172
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    January 2, 2025
    Report Date
    March 24, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL: (B)(6), BATCH: (B)(6). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL: (B)(6), BATCH: (B)(6).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL SUBMITTED TO INCLUDE CORRECTION TO THE INITIAL REPORT MDR IN BLOCK(S) H11. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408740. MODEL: SC-2408-74. SERIAL: (B)(6). BATCH: 7073070. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408740. MODEL: SC-2408-74. SERIAL: (B)(6). BATCH: 7072956.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662328 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 211613 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention