BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 21665387 · Received March 21, 2025

    Report

    Report Number
    3006630150-2025-01705
    Event Type
    Injury
    Date Received
    March 21, 2025
    Date of Event
    August 1, 2022
    Report Date
    May 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN AUGUST 2022 PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408740. MODEL:SC-2408-74. SERIAL: (B)(6). BATCH: 7070191. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2408740. MODEL: SC-2408-74. SERIAL: (B)(6). BATCH: 7070269. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN DUE TO INADEQUATE STIMULATION AND UNDESIRED SENSATION DUE TO OVERSTIMULATION. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN DUE TO INADEQUATE STIMULATION AND UNDESIRED SENSATION DUE TO OVERSTIMULATION. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546719 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 508266 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention