BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22474005 · Received July 10, 2025

    Report

    Report Number
    3006630150-2025-05371
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    June 17, 2025
    Report Date
    August 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336700. MODEL: SC-8336-70. SERIAL: (B)(6). BATCH: 7071645. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336700. MODEL: SC-8336-70. SERIAL: (B)(6). BATCH: 7071645. UDI: (B)(4).

    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 CURRENT LOCATION OF THE DEVICE REMAINS UNKNOWN. 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 CURRENT LOCATION OF THE DEVICE REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION CONFIRMS THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DURING AN ELECTIVE REPLACEMENT PROCEDURE. THE PATIENT ELECTED TO PROCEED WITH EXPLANTATION DUE TO RESOLUTION OF CHRONIC PAIN AND A DESIRE TO OBTAIN MRI COMPATIBILITY. POSTOPERATIVE RECOVERY HAS BEEN EXCELLENT, WITH THE PATIENT REPORTING NO COMPLICATIONS. PER FACILITY POLICY, THE EXPLANTED DEVICE WAS RETAINED AND WILL NOT BE RETURNED. AS THERE ARE NO REPORTABLE ALLEGATIONS RELATED TO DEVICE PERFORMANCE AND NO SERIOUS INJURY OCCURRED, THIS COMPLAINT HAS BEEN RECLASSIFIED AS NON-REPORTABLE IN ACCORDANCE WITH APPLICABLE CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678421 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 527204 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention