BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19668853 · Received July 3, 2024

    Report

    Report Number
    3006630150-2024-04276
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 11, 2024
    Report Date
    August 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    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: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6) /(B)(6). BATCH: 7081254/7081711.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THE THORACIC INCISION SITE. IT WAS UNKNOWN IF IT WAS DEVICE OR PROCEDURE RELATED. NO DEVICE MALFUNCTION WAS SUSPECTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD IMPAIRED WOUND HEALING, LEAKAGE FROM THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND OOZING AT THE THORACIC SCAR. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS INFECTION WAS INCISION RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICES WERE REMOVED AND DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THE THORACIC INCISION SITE. IT WAS UNKNOWN IF IT WAS DEVICE OR PROCEDURE RELATED. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THE THORACIC INCISION SITE. IT WAS UNKNOWN IF IT WAS DEVICE OR PROCEDURE RELATED. NO DEVICE MALFUNCTION WAS SUSPECTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD IMPAIRED WOUND HEALING, LEAKAGE FROM THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND OOZING AT THE THORACIC SCAR. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434618 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 599609 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention