BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIA VR

    MDR report key: 2790699 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02150
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Report Date
    January 28, 2013
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. EVALUATION SUMMARY: (B)(4) - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TIME OF RECOMMENDED REPLACEMENT (RRT) IN THE SAVE TO DISK ON (B)(4) 2012 DEVICE RRT WAS AT OR BELOW 2.6251 VOLT. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MINIMUM BATTERY OF 2.628 TO 2.608 VOLTS BETWEEN (B)(4) 2012. THERE WERE TWO PATIENT ALERTS FOR LOW BATTERY VOLTAGE ON (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS INITIALLY SHOWED NORMAL CURRENT DRAIN. WHEN THE STACKED CHIP SCALE PACKAGE (SCSP) WAS OPTICALLY INSPECTED, COPPER TRACE ANOMALIES WERE NOTED IN SEVERAL EXPOSED TRACES IN THE SCSP SUBSTRATE. ELECTRICAL SHORTS CONSISTENT WITH THE LOCATION OF THE ANOMALIES WERE SIMULATED ON A SYSTEM BREADBOARD. THE SIMULATIONS RESULTED IN HIGHER THAN NOMINAL CURRENT DRAIN CONSISTENT WITH THE OBSERVED DEPLETED BATTERY. HOWEVER, NO DEFINITIVE CONCLUSION CAN BE MADE FOR THE CAUSE OF FAILURE. THE BATTERY WAS SENT FOR ADDITIONAL ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH EXIT BLOCK. NO FURTHER INFORMATION COULD BE PROVIDED ABOUT THE LEAD. THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT) PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC S.A. D384VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R