BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO II DR

    MDR report key: 3991252 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14320
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CHARGE TIMEOUT CONDITION WAS NOT CONFIRMED. THE DEVICE WAS FULLY FUNCTIONAL THROUGHOUT THE ANALYSIS INCLUDING NOMINAL SYSTEM CURRENT DRAIN. THE DEVICE FUNCTIONED NOMINALLY WITH REGARDS TO PACING OUTPUT, LEAD IMPEDANCE, REGULATED SUPPLIES, AND REFERENCE VOLTAGES. THE DEVICE PASSED DIAGNOSTIC SYSTEM TESTING WHICH INCLUDED FAULT GRADE, INTERCONNECT, AND RANDOM ACCESS MEMORY TESTS. IT ALSO PASSED ADDITIONAL TESTING OF THE EXTERNAL SRAM. THE PRINTED CIRCUIT BOARD EDGES OF THE STACKED CHIP SCALE PACKAGE (SCSP) WERE INSPECTED WITH AN OPTICAL MICROSCOPE, AND NO COPPER ANOMALIES OR FOREIGN MATERIAL WERE OBSERVED. THE ANALYSIS WAS TERMINATED SINCE THE REPORTED CHARGE TIMEOUT FAILURE WAS NOT CONFIRMED. NO HYBRID ANOMALIES WERE FOUND, AND THE DEVICE MET ITS PROJECTED SERVICE LONGEVITY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 407652, LEAD, IMPLANTED: (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY CONTINUED: FURTHER ANALYSIS WAS PERFORMED ON THE BATTERY CELL. HIGH BATTERY IMPEDANCE WAS NOTED. EXAMINATION OF THE ANODE SHOWED MORE DISCHARGE ALONG THE EDGES. THIS SUGGESTS THE BATTERY SAW A HIGHER DEVICE DRAIN RATE, WHICH WOULD INCREASE THE DISCHARGE OF THE LITHIUM ALONG THE EDGES AND IN THE TURNS, AS SEEN IN THIS BATTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE LONG CHARGE TIMES ALONG WITH CHARGE CIRCUIT TIMEOUT, AND THAT THE DEVICE REACHED EOS (END OF SERVICE) IN LESS THAN FOUR YEARS. THE DEVICE WAS EXPLANTED 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
    468482 VIRTUOSO II DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R 694765 LEAD