BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET LEAD DOUBLE BEND, 86 CM

    MDR report key: 23013193 · Received September 10, 2025

    Report

    Report Number
    3006705815-2025-06578
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 13, 2025
    Report Date
    September 12, 2025
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    OJX
    UDI-DI
    05414734510189
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION ¿ G8 - MANUFACTURER REPORT NUMBER 3006705815-2025-06578 SUBMITTED ON SEP 10, 2025, THIS SHOULD HAVE STARTED WITH 2017865 INSTEAD.

    Additional Manufacturer Narrative · 0

    CORRECTION ¿ G8 : MANUFACTURER REPORT NUMBER 3006705815-2025-06578 SUBMITTED ON SEP 10, 2025, THIS SHOULD HAVE STARTED WITH 2017865 INSTEAD. MANUFACTURER REPORT NUMBER 2107865-2025-99799 SUBMITTED ON SEP 10, 2025, THIS SHOULD HAVE BEEN 2017865-2025-99853.

    Additional Manufacturer Narrative · 0

    THE STERILIZATION RECORDS WERE REVIEWED AND NO EVIDENCE OF ABNORMAL STERILIZATION CYCLE WAS FOUND. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH IMPROPER HEALING AND SLIGHT BROWNISH DRAINAGE AT THE INCISION SITE DURING A FOLLOW-UP IN CLINIC. PATIENT WAS TREATED WITH ANTIBIOTICS, AND THE ENTIRE SYSTEM WERE EXPLANTED DUE TO INFECTION - IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR (RV) LEAD, RIGHT ATRIAL (RA) LEAD AND LEFT VENTRICULAR (LV) LEAD ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2501515 QUARTET LEAD DOUBLE BEND, 86 CM DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 1457Q/86 A000156764 05414734510189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention