BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2813024 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06569
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    December 12, 2012
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS SUBMITTED IN THE INITIAL REGULATOR REPORT WAS NOT THE CORRECT INFORMATION FOR THIS PRODUCT. THE CORRECTED ANALYSIS IS AS FOLLOWS: PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED IT MET 80% OF EXPECTED 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND THE DEVICE DID NOT MEET EXPECTED LONGEVITY. ANALYSIS OF THE DEVICE AND INTERNAL COMPONENTS WERE AS EXPECTED FOR A PACEMAKER AT ERI (ELECTIVE REPLACEMENT INDICATOR). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MAY HAVE HAD PREMATURE BATTERY DEPLETION. 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
    1 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD