BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2811550 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06525
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    January 31, 2013
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4) THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 80% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SHOCKS AND WAS PRESENTED TO THE EMERGENCY ROOM. AN INTERROGATION SHOWED THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AND ALERT FOR HIGH IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) COIL. NOISE WAS NOTED ON THE RV PACE/SENSE PORTION. THERE WAS OVERSENSING RESULTING FROM A LEAD FRACTURE. THE RV LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT ATRIAL CHANNEL SHOWED NOISE. THE RIGHT ATRIAL (RA) LEAD WAS CAPPED AS REUSABLE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NEAR ELECTIVE REPLACEMENT INDICATOR AFTER ONLY 5.5 YEARS OF USE AND HAD SHORTENED LONGEVITY. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL, INC. D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R