BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2053322 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05864
    Event Type
    Injury
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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): 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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

    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 DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED ACTUAL LONGEVITY IS LESS THAN 80% OF 99.9% LONGEVITY LIMIT. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. 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 OVERSESNING 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; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 REACHED ELECTIVE REPLACEMENT INDICATOR AND WAS EXPLANTED AND REPLACED. 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 REACHED ELECTIVE REPLACEMENT INDICATOR AND WAS EXPLANTED AND REPLACED. 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.

    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. BOTH OF THE LEADS 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB