BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 17755224 · Received September 15, 2023

    Report

    Report Number
    3006630150-2023-05576
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    August 16, 2023
    Report Date
    September 15, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(6); BATCH: 7082789/7082903.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AROUND THE IPG SITE. SYMPTOMS OF ABSCESS, BACK PAIN, FEVER, BODY ACHES AND FLUID DISCHARGES WERE NOTED. THE PHYSICIAN DOES NOT BELIEVE THAT THE INFECTION WAS DEVICE OR PROCEDURE RELATED AND CAUSE WAS UNKNOWN. THE PATIENT WAS GIVEN ANTIBIOTICS. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328301 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 216047 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention