BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 18210292 · Received November 27, 2023

    Report

    Report Number
    3006630150-2023-07366
    Event Type
    Injury
    Date Received
    November 27, 2023
    Date of Event
    June 27, 2023
    Report Date
    August 12, 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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI. UPN: M365SC8416700. MODEL: SC-8416-70. SERIAL: (B)(6). BATCH: 7070048.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN BLOCKS B5, H6, AND H11. CORRECTION PROVIDED IN BLOCKS B6 AND H6: IMPACT CODES. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI. UPN: M365SC8416700. MODEL: SC-8416-70. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN IPG UPGRADE PROCEDURE, THE PATIENT HAD AN INFECTION ON BOTH IPG AND LEAD INCISION SITES. SIGNS AND SYMPTOMS OF REDNESS AND SWELLING WERE NOTED. IT WAS ALSO STATED THAT THE PATIENTS LEAD HAD MIGRATED AND THE PATIENT WAS EXPERIENCING PAIN UP, DOWN HIS BACK AND AT IPG POCKET. NO DEVICE MALFUNCTION SUSPECTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS PROCEDURE RELATED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEAD WERE EXPLANTED. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN IPG UPGRADE PROCEDURE, THE PATIENT HAD AN INFECTION ON BOTH IPG AND LEAD INCISION SITE. SIGNS AND SYMPTOMS OF REDNESS AND SWELLING WERE NOTED. IT WAS ALSO STATED THAT THE PATIENT LEAD HAD MIGRATED AND THE PATIENT WAS EXPERIENCING PAIN UP, DOWN HIS BACK AND AT IPG POCKET. NO DEVICE MALFUNCTION SUSPECTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS PROCEDURE RELATED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEAD WERE EXPLANTED. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT AROUND THE TIME WHEN THE INFECTION OCCURRED, THE PATIENT EXPERIENCED MOTOR AND MUSCLE WEAKNESS, HAD DIFFICULTY WALKING, PAIN IN THE LOWER BACK AND LEGS, AND TREMORS. THE PATIENT WAS DIAGNOSED WITH PARAPLEGIA AND SUBSEQUENTLY WAS HOSPITALIZED AND HAD THE EXPLANT PROCEDURE DUE TO INFECTION THE FOLLOWING DAY AFTER THESE SYMPTOMS OCCURRED. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186620 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 568675 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention| O