BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME

    MDR report key: 24276174 · Received February 6, 2026

    Report

    Report Number
    3006630150-2026-00743
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    January 16, 2026
    Report Date
    April 3, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    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. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI. UPN: M365SC8436500. MODEL: SC-8436-50. SERIAL: (B)(6). BATCH: 7090244. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ALL EXPLANTED DEVICES WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THAT ALL DEVICES MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. INVESTIGATION CONCLUSION: ALL EXPLANTED DEVICES WERE NOT RETURNED FOR ANALYSIS AND THE COMPLAINT AS REPORTED COULD NOT BE CONFIRMED. RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE COMPLAINT AND THE CONCLUSION CODE KNOWN INHERENT RISK OF DEVICE WILL BE USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET INCISION SITE WITH SIGNS AND SYMPTOMS OF PALENESS, WEAKNESS AND IMPAIRED WOUND HEALING. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND SPINAL CORD STIMULATOR (SCS) PADDLE LEAD WERE EXPLANTED AND WAS DOING WELL POSTOPERATIVELY. CULTURES WERE TAKEN AND REVEALED MRS (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS) INFECTION. THE PATIENT WAS PLACED ON ANTIBIOTICS AND THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET INCISION SITE WITH SIGNS AND SYMPTOMS OF PALENESS, WEAKNESS AND IMPAIRED WOUND HEALING. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND SPINAL CORD STIMULATOR (SCS) PADDLE LEAD WERE EXPLANTED AND WAS DOING WELL POSTOPERATIVELY. CULTURES WERE TAKEN AND REVEALED MRS (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS) INFECTION. THE PATIENT WAS PLACED ON ANTIBIOTICS AND THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343553 WAVEWRITER ALPHA? PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 236826 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention