BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO DR

    MDR report key: 2130702 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03376
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    March 2, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED OVERSENSING AND 1 VENTRICULAR NON-SUSTAINED TACHYCARDIA (NST) EPISODE WITH AN AVERAGE VENTRICULAR CYCLE OF 130 MS ON (B)(6) 2011 01:37:26.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STORED AN EPISODE WITH RIGHT VENTRICULAR LEAD OVERSENSING OCCURRING AND THERE HAS BEEN INCREMENTAL INCREASES IN THE SHORT INTERVAL COUNTS (SICS) FOR QUITE SOME TIME. IT WAS ALSO REPORTED THAT THE DOCTOR FELT THE ISSUE WAS EXTERNAL INTERFERENCE WITH NO SPECIFIC ISSUES NOTED AT FOLLOW UP. IT WAS FURTHER REPORTED THAT THERE WAS A PATIENT TRANSMISSION WITH NO EPISODES NOTED, ALTHOUGH THERE WERE TWENTY-FIVE SHORT VENTRICLE-VENTRICLE (V-V) INTERVALS WHICH COULD BE ATTRIBUTED TO PREMATURE VENTRICULAR CONTRACTIONS (PVCS.) THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE HAD AN EPISODE WITH OVERSENSING AND THERE HAS BEEN INCREMENTAL INCREASES IN THE SHORT INTERVAL COUNTS (SICS) FOR QUITE SOME TIME. IT IS UNKNOWN IF THERE WAS ANY INTERVENTION. THE ICD REMAINS IN USE. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other 5568 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD