BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22216035 · Received June 16, 2025

    Report

    Report Number
    3006630150-2025-04462
    Event Type
    Injury
    Date Received
    June 16, 2025
    Date of Event
    March 31, 2025
    Report Date
    June 16, 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2318700, MODEL: SC-2318-70, SERIAL: (B)(6) , BATCH: 5001801/5002280, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A SMALL PINHOLE SIZED OPENING AT HER INCISION SITE WHERE HER IMPLANTABLE PULSE GENERATOR (IPG) IS AND PERSISTENT SEROUS DRAINAGE. INITIALLY SHE DEVELOPED SOME REDNESS THAT RESOLVED WITH A COURSE OF BACTRIM AND LINEZOLID. SINCE THAT TIME THE DRAINAGE HAS SIGNIFICANTLY IMPROVED; HOWEVER, SHE CONTINUES TO HAVE A SMALL PIN SIZED OPENING WITH OCCASIONAL DRAINAGE. THE PATIENT UNDERWENT EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL PRODUCT RETAINED BY THE FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502719 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 769304 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention