BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX LEAD

    MDR report key: 19888604 · Received August 1, 2024

    Report

    Report Number
    2649622-2024-20429
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    September 5, 2019
    Report Date
    August 1, 2024
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: DTBA1D1 ICD - IMPLANTED: (B)(6) 2016 ; 50. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RV LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. IT WAS ALSO STATED THAT THE RV LEAD EXHIBITED OUT OF RANGE (OOR) HIGH RV DEFIBRILLATION, SUPERIOR VENA CAVA (SVC) DEFIBRILLATION AND PACING IMPEDANCE. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED OOR HIGH PACING LV IMPEDANCE. THE LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884802 ATTAIN STARFIX LEAD DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention| H 694765 LEAD, 5076-52 LEAD