BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2122473 · Received June 13, 2011

    Report

    Report Number
    2647346-2011-00794
    Event Type
    Injury
    Date Received
    June 13, 2011
    Report Date
    September 26, 2019
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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. EVALUATION SUMMARY FOR (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS HIGH RESISTANCE/IMPEDANCE NOTED. THERE WAS A PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2010. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT CHANGE FOR MIN AND MAX A PACE, MIN AND MAX RV PACE= 880 TO INF OHMS UN-FILTERED DATA, BETWEEN (B)(6) 2010 AND (B)(6) 2011, THEN ALL IMPEDANCES RETURN TO A BASELINE IMPEDANCE ON (B)(6) 2011. THERE WAS OVERSENSING NOTED, AND A VENTRICULAR FIBRILLATION EPISODE SENSING ON (B)(6) 2009. THE BATTERY VOLTAGE WAS PRE/APPROACHING ELECTIVE REPLACEMENT INDICATOR. THE WEEKLY TREND IN SAVE TO DISK DATA SHOWS MIN BAT= 2.83 VOLTS IN WEEK OF (B)(6) 2011, IS BEFORE RECOMMENDED REPLACEMENT TIME OF 2.62 VOLT.

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED FOLLOW-UP REPORT #002 SHOULD HAVE BEEN SEQUENCED #001, REPORT #003 SHOULD HAVE BEEN SEQUENCED #002, AND REPORT #004 SHOULD HAVE BEEN SEQUENCED #003. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY FOR (B)(4): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS HIGH RESISTANCE/IMPEDANCE NOTED. THERE WAS A PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2010. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT CHANGE FOR MIN AND MAX A PACE, MIN AND MAX RV PACE= 880 TO INF OHMS UN-FILTERED DATA, BETWEEN (B)(4) 2010 AND (B)(4) 2011, THEN ALL IMPEDANCES RETURN TO A BASELINE IMPEDANCE ON (B)(4) 2011. THERE WAS OVERSENSING NOTED, AND A VENTRICULAR FIBRILLATION EPISODE SENSING ON (B)(4) 2009. THE BATTERY VOLTAGE WAS PRE/APPROACHING ELECTIVE REPLACEMENT INDICATOR. THE WEEKLY TREND IN SAVE TO DISK DATA SHOWS MIN BAT= 2.83 VOLTS IN WEEK OF (B)(4) 2011, IS BEFORE RECOMMENDED REPLACEMENT TIME OF 2.62 VOLT. ANALYSIS OF THE DEVICE IS IN PROCESS; T HE RESULTS WILL BE FORWARDED WHEN AVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A LITHOTRIPSY PROCEDURE THAT BOTH THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL LEAD HAD A ONE DAY INCREASE IN IMPEDANCE. IT WAS ALSO NOTED THAT AFTER THE PROCEDURE THE RV LEAD HAD AN INCREASED THRESHOLD. IT WAS LATER REPORTED THAT IMPEDANCE ON THE RV AND RA LEADS WERE HIGH, HAD FLUCTUATED AND THAT THERE WAS A PATIENT ALERT FOR AN RV LEAD OUT OF TOLERANCE IMPEDANCE. ALSO THE BATTERY VOLTAGE ON THE DEVICE WAS ALSO GOING DOWN FASTER THAN NORMAL SINCE THE LITHOTRIPSY PROCEDURE. THE LEADS AND DEVICE ARE STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A LITHOTRIPSY PROCEDURE THAT BOTH THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL LEAD HAD A ONE DAY INCREASE IN IMPEDANCE. IT WAS ALSO NOTED THAT AFTER THE PROCEDURE THE RV LEAD HAD AN INCREASED THRESHOLD. IT WAS LATER REPORTED THAT IMPEDANCE ON THE RV AND RA LEADS WERE HIGH, HAD FLUCTUATED AND THAT THERE WAS A PATIENT ALERT FOR AN RV LEAD OUT OF TOLERANCE IMPEDANCE. ALSO THE BATTERY VOLTAGE ON THE DEVICE WAS ALSO GOING DOWN FASTER THAN NORMAL SINCE THE LITHOTRIPSY PROCEDURE. THE LEADS ARE STILL IN USE. IT WAS LATER REPORTED 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MDT PUERTO RICO OPERATIONS CO, MED REL D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization| R| O