BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 90 CM

    MDR report key: 19561364 · Received June 18, 2024

    Report

    Report Number
    1627487-2024-09378
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 9, 2024
    Report Date
    June 18, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401678
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: OUATTRODE, MODEL: 3169, UDI: (B)(4), SERIAL: (B)(6), BATCH: 4950636. COMMON DEVICE NAME: OUATTRODE, MODEL: 3169, UDI: (B)(4), SERIAL: (B)(6), BATCH: 4950636.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEADS WERE REPLACED DUE TO ONE LEAD HAD BEEN CUT BY A PRIOR SURGERY (MANUFACTURER REFERENCE NUMBER: 1627487-2021-17979, 1627487-2021-17980) AND ONE MIGRATED. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED. NOTE: IT IS UNKNOWN WHICH LEAD WAS CUT OR MIGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766137 QUATTRODE LEAD WIDE SPACED, 90 CM SCS LEAD LGW ABBOTT MEDICAL 3169 4950636 05414734401678

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other