BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2952888 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01839
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 27, 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
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE ALLEGATIONS ARE UNCONFIRMED. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE TIME OF RECOMMENDED REPLACEMENT TIME (RRT) WAS (B)(6) 2012. THIS DEVICES RRT IS LESS THAN OR EQUAL TO 2.62 VOLT. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWED BATTERY VOLTAGE OF 2.66 TO 2.57 VOLTS BETWEEN (B)(6) 2012 AND (B)(6) 2012. LOW BATTERY VOLTAGE ALERT ON(B)(6) 2012 AND (B)(6) 2012. THERE WAS A PATIENT ALERT FOR CHARGE CIRCUIT TIMEOUT AND EXCESSIVE CHARGE TIME ON (B)(6) 2012. PROGRAMMER DATA SHOWED AN ALERT FOR CHARGE TIME OF GREATER THAN 30 SECONDS ON (B)(6) 2012.

    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 PRODUCTS: 6947, IMIPLANTABLE TACHY LEAD, (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  WENT FROM RECOMMENDED REPLACEMENT TIME (RRT) TO END OF SERVICE (EOS) FASTER THAN EXPECTED. PREMATURE DEPLETION WAS SUSPECTED. IT APPEARED VIA MONITORING THAT THE CHARGE CIRCUIT WASDISABLED. THE ICD 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
    56343 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD