BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS LEAD

    MDR report key: 20913425 · Received December 12, 2024

    Report

    Report Number
    2649622-2024-33621
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    November 26, 2024
    Report Date
    December 12, 2024
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: ADDRL1 IPG IMPLANTED (B)(6) 2010. 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 A DUAL CHAMBER PACEMAKER WAS INVOLVED IN AN OUT OF HOSPITAL CARDIAC ARREST (OOHCA) EVENT. THE PATIENT WAS RESUSCITATED AND IS CURRENTLY INTUBATED AND VENTILATED IN THE INTENSIVE CARE UNIT. THE DEVICE WAS PERFORMING IN RECOMMENDED REPLACEMENT TIME (RRT) MODE OF VVI 65 BEAT PER MINUTE (BPM), WHICH MAY HAVE CONTRIBUTED TO THE OOHCA. HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE EVENT. THE DEVICE WAS DISPLAYING END OF LIFE BEHAVIOR, WITH THE BATTERY AT THE END OF SERVICE NEEDING IMMEDIATE REPLACEMENT. THE RIGHT VENTRICULAR (RV) LEAD WAS FAILING TO CAPTURE AT MAXIMUM OUTPUT IN BOTH SETTINGS. A CHEST X-RAY SUGGESTED RIGHT VENTRICULAR (RV) LEAD PERFORATION, WITH THE TIP OUTSIDE THE CARDIAC SILHOUETTE, POSSIBLY CAUSED BY CARDIOPULMONARY RESUSCITATION. THERE WAS A POSSIBLE RV LEAD FRACTURE, HIGH AND LOW IMPEDANCE, AND INSULATION DAMAGE. IT WAS ALSO NOTED THE RV LEA MAY HAVE DISLODGED AND HAD HIGH THRESHOLDS. DIAGNOSTIC TESTING AND TROUBLESHOOTING WERE PERFORMED, AND REPROGRAMMING WAS CONDUCTED. THE RV LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146090 CAPSURE SP NOVUS LEAD PERMANENT PACEMAKER ELECTRODE DTB MPRI 4092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H 4592-53 LEAD