BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO II VR

    MDR report key: 3991294 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14317
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    March 20, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0118-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE WAS INCONCLUSIVE. THE DEVICE WAS RETURNED AFTER 50 MONTHS DUE TO PREMATURE BATTERY DEPLETION. THE DEVICE HAD REACHED ITS RECOMMENDED REPLACEMENT TIME (RRT) MEETING 57% OF ITS PROJECTED LIFE. IN ADDITION, RAPID BATTERY DEPLETION WAS OBSERVED IN THE BATTERY TREND CURVE. THE DEVICE WAS FULLY FUNCTIONAL WHEN RECEIVED INTO THE RETURNED PRODUCT ANALYSIS LABORATORY (RPA) WITH A TELEMETERED BATTERY VALUE OF 2.61 VOLTS. PAL ANALYSIS OF THE DEVICE CONFIRMED THE LOW BATTERY VOLTAGE. THE INITIAL IN CAN CURRENT DRAIN (ICCD) TESTS MEASURED A SLIGHTLY HIGHER THAN NOMINAL CURRENT DRAIN. AFTER DISCONNECTING THE BATTERY, THE ELEVATED CURRENT DRAIN CONDITION WAS NO LONGER OBSERVED. THE DEVICE WAS FULLY FUNCTIONAL, WITH NOMINAL VALUES SEEN FROM THE PACING OUTPUT, LEAD IMPEDANCE, REGULATED SUPPLIES, AND REFERENCE VOLTAGES. THE DEVICE PASSED DIAGNOSTIC SYSTEM TESTING WHICH INCLUDED INTERCONNECT, FAULT GRADE, AND RANDOM ACCESS MEMORY (RAM) TESTING. THE PRINTED CIRCUIT BOARD EDGES OF THE STACKED CHIP SCALE PACKAGE (SCSP) WERE INSPECTED WITH AN OPTICAL MICROSCOPE. NO COPPER ANOMALIES OR FOREIGN MATERIAL WERE OBSERVED. NO HYBRID ANOMALIES WERE FOUND. THE CAUSE FOR THE RAPID BATTERY DEPLETION WAS NOT DETERMINED.

    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: 5076-45, LEAD, IMPLANTED: (B)(6) 2003. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) PREMATURELY. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468311 VIRTUOSO II VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R 694758 LEAD