BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME

    MDR report key: 22553121 · Received July 21, 2025

    Report

    Report Number
    3006630150-2025-05692
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    June 24, 2025
    Report Date
    September 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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: 7163013. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7162613. UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. SERIAL: NA. BATCH: 35867243. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A SUSPECTED INFECTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION WAS AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT DEVICE RELATED, HOWEVER, THE CAUSE WAS UNKNOWN. THE PHYSICIAN WAS ALSO UNABLE TO DETERMINE IF IT WAS RELATED TO THE RECENT PROCEDURE. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND WAS DOING WELL UPON FOLLOW-UP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A SUSPECTED INFECTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2753059 WAVEWRITER ALPHA? PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 236594 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention