BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2953451 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01961
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 19, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. EVALUATION SUMMARY: (B)(4). THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS REVEALED NORMAL BATTERY DEPLETION. CONCOMITANT MEDICAL PRODUCTS: 6947 IMPLANTABLE DEFIB LEAD: (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    PERFORMANCE DATA FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THERE WAS A PATIENT ALERT FOR LOW BATTERY VOLTAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED AN UNEXPECTED LONGEVITY LASTING LESS THAN FIVE YEARS. 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 EXPERIENCED AN UNEXPECTED LONGEVITY LASTING LESS THAN FIVE YEARS. 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
    56627 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD