BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 15245437 · Received August 17, 2022

    Report

    Report Number
    3006630150-2022-04135
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    July 28, 2022
    Report Date
    September 7, 2022
    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

    EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(6), BATCH: 7072217.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED INFECTION AT THE IPG SITE. SIGN OF LEAKING AND OOZING WERE REPORTED. CAUSED OF INFECTION WAS UNKNOWN. ANTIBIOTICS WERE PRESCRIBED AND PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED INFECTION AT THE IPG SITE. SIGN OF LEAKING AND OOZING WERE REPORTED. CAUSED OF INFECTION WAS UNKNOWN. ANTIBIOTICS WERE PRESCRIBED AND PATIENT UNDERWENT AN EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED AS THEY WERE NOT RELEASED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2737182 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 209777 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention