BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 22311763 · Received June 23, 2025

    Report

    Report Number
    3006630150-2025-04783
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    May 29, 2025
    Report Date
    June 23, 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
    FL, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7162290/7162149. UDI: (B)(4). UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE INCISION SITE. IT WAS MENTIONED THAT PATIENT HAD BEEN REUSING USED BANDAGES AFTER SURGERY LONGER THAN RECOMMENDED WHICH MAY HAVE CONTRIBUTED TO THE INFECTION. THE PHYSICIAN ALSO BELIEVES THAT IT WAS DUE TO CLINDAMYCIN. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ANTIBIOTICS WAS PRESCRIBED. NOTHING WILL BE RETURNED AS IT WAS SENT TO PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064337 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 761507 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention