BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO II DR

    MDR report key: 4163182 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19270
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0117-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION.  PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE DID NOT DETECT ANY PERFORMANCE ISSUES, BUT THE CALCULATED LONGEVITY RESULT OF 85% OF EXPECTED WAS LESS THAN THE PREDICTED VALUE BASED ON THE AVAILABLE PROGRAMMED PARAMETERS. IN THE ABSENCE OF THE COMPLETE PROGRAMMING HISTORY, IT IS NOT POSSIBLE TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. A CHARGE CIRCUIT TIMEOUT OCCURRED ON 07 SEP 2014 WHICH IS AFTER THE DEVICE WAS EXPLANTED. CONCOMITANT MEDICAL PRODUCTS: 4574-45 LEAD, IMPLANTED: (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE RETURNED DEVICE INDICATED SHORTING/LOW IMPEDANCE IN THE BATTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER ONLY 4.5 YEARS. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE PACING AND HAD NEVER RECEIVED A SHOCK. 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
    644324 VIRTUOSO II DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R 6947-58 LEAD