BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2952532 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01746
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 19, 2012
    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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVALUATION SUMMARY: WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS REVEALED THERE WAS AN ALERT DUE TO REACHING THE TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN THE SAVE TO DISK WHICH WAS ON (B)(4) 2012 DEVICE RRT LESS THAN EQUAL TO 2.62 VOLT. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT EQUAL TO 2.64 TO 2.62 VOLTS BETWEEN (B)(4) 2012. THE LOW BATTERY VOLTAGE ALERT WAS ON (B)(4) 2012. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD: 2008-06-13. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND THERE WAS POSSIBLE EARLY BATTERY DEPLETION. IT WAS NOTED THAT THE DEVICE HAD MULTIPLE CHARGES OVER THE LIFE OF THE DEVICE AND THE PRE-ELECTROGRAM MONITORING AND STORAGE HAD BEEN PROGRAMMED ON. 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
    56212 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R 6947 IMPLANTABLE DEFIBRILLATION LEAD