BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1875331 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11665
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    July 7, 2010
    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
    CA, 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. THERE WAS NO RV (RIGHT VENTRICULAR) CAPTURE AT MAXIMUM OUTPUT, AND RV SENSING APPEARED TO HAVE FLUCTUATED SINCE IMPLANT. ATRIAL SENSING WAS REPORTED TO BE "A LITTLE LOW." A DROP IN RV IMPEDANCE JUST AFTER IMPLANT WAS QUESTIONED, SINCE IMPLANT IMPEDANCE WAS AROUND 800 OHMS AND THE CURRENT MEASUREMENT WAS 380 OHMS. THE RV LEAD WAS EXPLANTED AND REPLACED, AND THE ATRIAL LEAD AND DEVICE REMAIN IN USE. DURING REPOSITIONING, IT WAS OBSERVED THAT THE HELIX OF THE RV LEAD WOULD NOT EXTEND. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. EVALUATION SUMMARY: (B)(4) HELIX DISENGAGED FROM HELICAL CHANNEL; FULL LEAD RETURNED AND ANALYZED. THE HELIX WAS FOUND TO BE OVER-RETRACTED AND WOULD NOT EXTEND WITH 22 TURNS. NO ELECTRICAL PROBLEMS WERE FOUND WITH THE LEAD. THERE WAS A TIP SEAL OBSERVATION, AND BLOOD WAS PRESENT IN/ON THE HELIX MECHANISM. (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND FOUND THE LEAD INTEGRITY ALERT CRITERIA WAS MET BASED ON SENSING AND SIC. "LEAD FAILURE PREDICTOR" PATIENT ALERT SOUNDED (B)(6) 2010. THE AVERAGE SHORT INTERVALS WERE 76 V-SIC / DAY IN 8 DAYS SINCE LAST SESSION. LIFETIME TOTAL OF 648 V-SIC / 11.9 DAYS. THERE WERE 5 SHORT V-V CYCLES (<220MS PERIOD) NOTED ON (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THERE WAS NO RV (RIGHT VENTRICULAR) CAPTURE AT MAXIMUM OUTPUT, AND RV SENSING APPEARED TO HAVE FLUCTUATED SINCE IMPLANT. ATRIAL SENSING WAS REPORTED TO BE "A LITTLE LOW." A DROP IN RV IMPEDANCE JUST AFTER IMPLANT WAS QUESTIONED, SINCE IMPLANT IMPEDANCE WAS AROUND 800 OHMS AND THE CURRENT MEASUREMENT WAS 380 OHMS. THE RV LEAD WAS EXPLANTED AND REPLACED, AND THE ATRIAL LEAD AND DEVICE REMAIN IN USE. DURING REPOSITIONING, IT WAS OBSERVED THAT THE HELIX OF THE RV LEAD WOULD NOT EXTEND. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. EVALUATION SUMMARY: (B)(4) HELIX DISENGAGED FROM HELICAL CHANNEL; FULL LEAD RETURNED AND ANALYZED. THE HELIX WAS FOUND TO BE OVER-RETRACTED AND WOULD NOT EXTEND WITH 22 TURNS. NO ELECTRICAL PROBLEMS WERE FOUND WITH THE LEAD. THERE WAS A TIP SEAL OBSERVATION, AND BLOOD WAS PRESENT IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FEELING STIMULATION INTERMITTENTLY, EVEN WHEN NOT PACING. THE ATRIAL LEAD HAD DROPPED TO THE FLOOR OF THE ATRIA. POSSIBLE OVERSENSING DUE TO CROSSTALK WAS ALSO SEEN ON NST (NON-SUSTAINED TACHYCARDIA) EPISODES, AND UNEXPLAINED MARKER CHANNELS THAT DO NOT CORRELATE WITH HEART ACTIVITY WAS ALSO NOTED. LIA (LEAD INTEGRITY ALERT) TRIPPED DUE TO NST AND SIC (SHORT INTERVAL COUNT) INCREMENT. FURTHER TESTING WAS RECOMMENDED, INCLUDING ISOMETRIC EXERCISES AND POCKET MANIPULATION. IT WAS FURTHER REPORTED THE PATIENT HAD SHARP ELECTRICAL PULSES IN THE LEFT SIDE OF THE HEART, WHICH OCCURRED DAILY, WITH VARYING DEGREES OF STRENGTH. THE ATRIAL AND VENTRICULAR THRESHOLDS WERE FOUND TO HAVE INCREASED SIGNIFICANTLY, RESULTING IN INCREASED OUTPUTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FEELING STIMULATION INTERMITTENTLY, EVEN WHEN NOT PACING. THE ATRIAL LEAD HAD DROPPED TO THE FLOOR OF THE ATRIA. POSSIBLE OVERSENSING DUE TO CROSSTALK WAS ALSO SEEN ON NST (NON-SUSTAINED TACHYCARDIA) EPISODES, AND UNEXPLAINED MARKER CHANNELS THAT DO NOT CORRELATE WITH HEART ACTIVITY WAS ALSO NOTED. LIA (LEAD INTEGRITY ALERT) TRIPPED DUE TO NST AND SIC (SHORT INTERVAL COUNT) INCREMENT. FURTHER TESTING WAS RECOMMENDED, INCLUDING ISOMETRIC EXERCISES AND POCKET MANIPULATION. IT WAS FURTHER REPORTED THE PATIENT HAD SHARP ELECTRICAL PULSES IN THE LEFT SIDE OF THE HEART, WHICH OCCURRED DAILY, WITH VARYING DEGREES OF STRENGTH. THE ATRIAL AND VENTRICULAR THRESHOLDS WERE FOUND TO HAVE INCREASED SIGNIFICANTLY, RESULTING IN INCREASED OUTPUTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention