BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 1990073 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00625
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    Z-0128-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. DETAILED ANALYSIS OF THE DEVICE WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT. THIS EVENT INVOLVES A LEGAL CASE IN PROGRESS OR POTENTIAL LITIGATION. THE PROPRIETARY NATURE OF THE EVENT MAY AFFECT FOLLOW UP EFFORTS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. THE DEVICE PROJECTED TO LAST 56% OF ITS PROJECTED LONGEVITY.

    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) ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. THE DEVICE PROJECTED TO LAST 56% OF ITS PROJECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATORS (ERI) EARLY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATORS (ERI) EARLY. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT A LAWSUIT ALLEGED THAT THE PATIENT SUSTAINED PHYSICAL INJURIES DUE TO A DEFECT IN THE PRODUCT. NO 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 60 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD