BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 4498313 · Received February 10, 2015

    Report

    Report Number
    2182208-2015-00542
    Event Type
    Injury
    Date Received
    February 10, 2015
    Date of Event
    August 1, 2014
    Report Date
    December 1, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE PMA NUMBER FOR THIS REPORT LISTED IS PART OF A COMBINATION OF PMAS CONSIDERED THE "1-CARD" AND CONSISTS OF P820003, P850051, P890003, P930022, P970012 AND P980035. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: EXTREME ELECTRICAL STORM IN A PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. ISR. MED. ASSOC. J. 2014;16(8):513-515. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ARTICLE INDICATED THAT THE PATIENT HAD SUCCESSFUL CORONARY INTERVENTION SURGERY; AFTER THE SEVENTH DAY OF HOSPITALIZATION A "SEVERE ELECTRICAL STORM" OCCURRED. MEDICATION WAS GIVEN TO REDUCE THE FREQUENCY OF VENTRICULAR TACHYCARDIA (VT); BUT PROVED TO BE UNSUCCESSFUL. THE PATIENT HAD RECEIVED A TOTAL OF 104 SHOCKS FROM THE DEVICE; AND THUS, THE BATTERY OF THE DEVICE REACHED ITS END OF SERVICE; AND SUBSEQUENTLY THE PATIENT HAD TO BE EXTERNALLY DEFIBRILLATED. THE PATIENT THEN UNDERWENT A SECOND SUCCESSFUL CORONARY INTERVENTION. THE MANAGED VENTRICULAR PACING (MVP) MODE WAS TURNED OFF AND MEDICATIONS WERE AGAIN TRIED WITH A LITTLE SUCCESS. THE PATIENT HAD AN ABLATION PROCEDURE AND A FEW WEEKS LATER, THE ICD WAS REPLACED. TWO MONTHS AFTER THE REPLACEMENT OF THE ICD, THERE WAS NO EVIDENCE OF " RECURRENT VENTRICULAR ARRHYTHMIAS. THE REPLACEMENT ICD REMAINS IN USE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99584 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. D164AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R