BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO VR

    MDR report key: 7417762 · Received April 10, 2018

    Report

    Report Number
    9614453-2018-01134
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    February 22, 2018
    Report Date
    November 8, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THAT THE VENTRICULAR TACHYARRHYTHMIA THERAPY ENERGY WAS LOW. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. THE BATTERY INDICATOR SIGNIFYING THAT IT IS TIME FOR DEVICE REPLACEMENT OCCURRED AFTER EXPLANT. ANALYSIS OF THE DEVICE MEMORY INDICATED THAT THE VENTRICULAR TACHYARRHYTHMIA THERAPY ENERGY WAS LOW. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTIONS: PMA/510K: CFN 694765; APPROVAL NUMBER P920015; FDA PROVIDED CODE LWS; ORIGINAL APPROVED DATE 11/02/2001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED LESS ENERGY THAT WHAT IS WAS PROGRAMMED TO DELIVER WHEN ATTEMPTED TO CONVERT A PATIENT RHYTHM. IT WAS DISCOVERED THAT THE DEVICE HAD A SHORT CIRCUIT. 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 FURTHER REPORTED THAT RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED OF HAVING AN INSULATION BREACH. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254957 VIRTUOSO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA 694765 LVV7354214

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R