BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z

    MDR report key: 4833801 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06950
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    January 4, 2015
    Report Date
    April 29, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS INFORMATION -- (B)(6) 2015 19:35:23 CST PLI# 10, PRODUCT ID# ADDR03 (B)(6) 2015, S2D, (B)(4): THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. ANALYST COMMENTED, NO ANOMALIES FOUND ON SAVE TO DISK. NOTED VENTRICULAR CAPTURE MANAGEMENT AVERAGE THRESHOLD MEASUREMENTS WITHIN NORMAL RANGE OF 1.125V TO 1.75 V THROUGHOUT RECORD UNTIL VENTRICULAR CAPTURE MANAGEMENT WAS REPROGRAMMED OFF.<(><<)>END> ANALYSIS INFORMATION -- (B)(6) 2015 19:28:44 CST PLI# 20, PRODUCT ID# 5034 (B)(6) 2015, S2D, (B)(4): THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. ANALYST COMMENTED, NO ANOMALIES FOUND ON SAVE TO DISK. NOTED VENTRICULAR CAPTURE MANAGEMENT AVERAGE THRESHOLD MEASUREMENTS WITHIN NORMAL RANGE OF 1.125V TO 1.75 V THROUGHOUT RECORD.<(><<)>END> CONCOMITANT PRODUCT: PRODUCT ID ADDR03, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT AND HAD ENCOUNTERED PRE-SYNCOPE EPISODE. IT WAS ALSO REPORTED THAT DURING A FOLLOW VISIT FOR THE PRE SNYCOPE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS RE-PROGRAMMED WITH RESPECT TO UP-RATE TIMING AND DATA COLLECTION, AND THE IPG REMAINED IN USE. THE PATIENT PRESENT FOR FOLLOW UP VISIT AND COMPLAINED OF CONTINUED LIGHTHEADEDNESS. THE IPG WAS INTERROGATED, AND CHANGES WERE MADE TO PATIENT MEDICATIONS. IT WAS ALSO REPORTED THAT THE PATIENT LATER SUFFERED A FALL, ENCOUNTERED HEAD AND NECK INJURIES AND EVENTUALLY REQUIRED INTUBATION/MECHANICAL VENTILATION. THE PHYSICIAN ALSO ALLEGED CONCERNS VIS-A-VIS CAPTURE MANAGEMENT ASPECT OF THE IPG. AT SOME POINT, DURING PATIENT'S CARE, RIGHT VENTRICULAR (RV) LEAD NON-CAPTURE WAS OBSERVED WITH IN-HOUSE MONITORING AND ELEVATED THRESHOLDS WITH ADJUSTMENT TO LEAD SETTINGS. THE RV LEAD AND IPG REMAIN IN USE, AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378514 CAPSURE Z ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5034

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| L| R ADDR03 IPG