BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 1875358 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05493
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    July 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    Z-0128-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT INQUIRED ABOUT LONGEVITY AND BATTERY VOLTAGE AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND BEGINNING VOLTAGE. THE PATIENT ALSO INDICATED THAT "DEVICE WAS FAULTY" AND INQUIRED ABOUT WHAT HAPPENS IF DEVICE BATTERY DEPLETES SOON, ABOUT REIMBURSEMENT FOR MEDICAL BILLS, PAIN AND SUFFERING, AND TRAVEL, AND ALSO SAID "I'VE ONLY HAD DEVICE LESS THAN 4 YEARS". 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD