BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2951581 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01569
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 2, 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
    FL, 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 EVENT SUMMARY: A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS FOUND THE CAUSE OF THE HIGH CURRENT DRAIN TO BE CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. PERFORMANCE DATA WAS RECEIVED AND ANALYZED. BATTERY DEPLETION WAS INDICATED AS THE TIME OF RECOMMENDED REPLACEMENT TIME IN THE SAVE TO DISK WAS ON (B)(4) 2012 AT <=2.62 VOLTS. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOW MINIMUM BATTERY WAS 2.64 TO 2.62 VOLTS BETWEEN (B)(4) 2012. ONE LOW BATTERY VOLTAGE ALERT OCCURRED ON (B)(4) 2012. CONCOMITANT MEDICAL PRODUCTS: 1688T COMPETITOR IMPLANTABLE PACING LEAD: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY DEPLETED EARLIER THAN EXPECTED. THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57468 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD