BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 3071651 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06700
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THE DEVICE LONGEVITY AND BATTERY DATA SHOWED THAT THE DEVICE WENT TO ELECTIVE REPLACEMENT INDICATOR ON (B)(4) 2013. CONCOMITANT THERAPY: 5076-52 IMPLANTABLE PACING LEAD: IMPLANTED: (B)96) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE FOUND A HIGH CURRENT DRAIN CONDITION DUE TO CURRENT LEAKAGE IN A CERAMIC CAPACITOR. ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY INDICATOR SIGNIFYING THAT IT IS TIME FOR DEVICE REPLACEMENT, JONESL2 (B)(6) 2013: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THE DEVICE LONGEVITY AND BATTERY DATA SHOWED THAT THE DEVICE WENT TO ELECTIVE REPLACEMENT INDICATOR ON (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE FOLLOW-UP THE DEVICE SHOWED THAT IT WENT TO ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE DEVICE LASTED LESS THAN 5 YEARS. PREMATURE BATTERY DEPLETION IS SUSPECTED. 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
    172497 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R 694765 IMPLANTABLE TACHY LEAD