BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2791056 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15396
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    February 25, 2012
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA WAS COLLECTED AND ANALYZED. A LEAD INTEGRITY ALERT TRIGGERED FOR LEAD FAILURE PREDICTOR ON (B)(4) 2012. OVERSENSING: 1 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODE AT 210 MS ON (B)(4) 2012 AND ONE VENTRICULAR (V.) FIBRILLATION EPISODE AT 190 MS ON (B)(4) 2012. INTERFERENCE/NOISE: THE V. SHORT INTERVAL COUNT WAS 50 COUNTS IN 0.86 DAY BETWEEN (B)(4) 2012. LOW RESISTANCE/IMPEDANCE: 1 PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2012. WEEKLY HIGH VOLTAGE-LEAD IMPEDANCE TREND DATA SHOWS AN IMPEDANCE DECREASE FOR MINIMUM DEFIBRILLATOR ACTIVE CAN ON IMPEDANCE WAS 50 TO 0 OHMS MINIMUM (UN-FILTERED DATA) BETWEEN (B)(4) 2012. HIGH RESISTANCE/IMPEDANCE: 1 PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2012. 1 ALERT EVENT FOR "RV BIPOLAR LEAD IMPEDANCE GREATER THAN 3000 OHMS" ON (B)(4) 2012. BATTERY VOLTAGE (BV) WAS APPROACHING ELECTIVE REPLACEMENT INDICATOR. WEEKLY BV TREND DATA SHOWS MINIMUM BATTERY WAS 3.103 TO 2.938 VOLTS BETWEEN (B)(4) 2012 IS BEFORE DEVICE RECOMMENDED REPLACEMENT TIME LESS THAN OR EQUAL TO 2.6251 VOLTS. THE DEVICE WAS RETURNED AND ANALYSIS WAS INCONCLUSIVE.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. OVERSENSING WAS NOTED WITH ONE VENTRICULAR NON-SUSTAINED (NS) TACHYCARDIA EVENT =210 MS ON (B)(6) 2012. THERE WAS ONE LEAD FAILURE PREDICTOR HIGH RATE-NS = 120 MS AVERAGE V-CYCLE ON (B)(6) 2012. THERE WAS ONE VENTRICULAR FIBRILLATION (VF)=190 MS AVERAGE V-CYCLE ON (B)(6) 2012. THE LEAD INTEGRITY ALERT TRIGGERED WITH ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012. THERE WAS A RESISTANCE/IMPEDANCE INCREASE. THE WEEKLY PACE IMPEDANCE TREND DATA SHOWS A SPIKE INCREASE FOR MAXIMUM VENTRICULAR PACE BIPOLAR IMPEDANCE= 513 TO 893 OHMS PEAK BETWEEN (B)(6) 2012 THEN RETURNING TO 532 OHMS ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA WAS COLLECTED AND ANALYZED. A LEAD INTEGRITY ALERT TRIGGERED FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012. OVERSENSING: 1 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODE AT 210 MS ON (B)(6) 2012 AND ONE VENTRICULAR (V.) FIBRILLATION EPISODE AT 190 MS ON (B)(6) 2012. INTERFERENCE/NOISE: THE V. SHORT INTERVAL COUNT WAS 50 COUNTS IN 0.86 DAY BETWEEN (B)(6) 2012. LOW RESISTANCE/IMPEDANCE: 1 PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. WEEKLY HIGH VOLTAGE-LEAD IMPEDANCE TREND DATA SHOWS AN IMPEDANCE DECREASE FOR MINIMUM DEFIBRILLATOR ACTIVE CAN ON IMPEDANCE WAS 50 TO 0 OHMS MINIMUM (UN-FILTERED DATA) BETWEEN (B)(6) 2012. HIGH RESISTANCE/IMPEDANCE: 1 PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. 1 ALERT EVENT FOR "RV BIPOLAR LEAD IMPEDANCE GREATER THAN 3000 OHMS" ON (B)(6) 2012. BATTERY VOLTAGE (BV) WAS APPROACHING ELECTIVE REPLACEMENT INDICATOR. WEEKLY BV TREND DATA SHOWS MINIMUM BATTERY WAS 3.103 TO 2.938 VOLTS BETWEEN (B)(6) 2012 IS BEFORE DEVICE RECOMMENDED REPLACEMENT TIME LESS THAN OR EQUAL TO 2.6251 VOLTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE TRIGGERED A PATIENT ALERT. AN INTERROGATION SHOWED NO IMPEDANCE VALUES FOR THE HVB (HIGH VOLTAGE B) RV (RIGHT VENTRICULAR) LEAD BUT DID SHOW AN IMPEDANCE VALUE FOR THE SVC (SUPERIOR VENA CAVA) RV LEAD EVEN THOUGH THERE IS NO SVC LEAD IMPLANTED. THE DEVICE BATTERY VOLTAGE WAS QUICKLY DEPLETING AND WAS NEARING RRT (RECOMMENDED REPLACEMENT TIME). IT WAS FURTHER REPORTED THAT ANOTHER PATIENT ALERT TRIGGERED FOR OVERSENSING ON THE RV LEAD. AN INAPPROPRIATE SHOCK WAS DELIVERED. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LEAD REMAINS IN USE. NO FURTHER 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD