BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3509450 · Received December 10, 2013

    Report

    Report Number
    2649622-2013-14006
    Event Type
    Injury
    Date Received
    December 10, 2013
    Date of Event
    September 5, 2013
    Report Date
    September 5, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE, THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET, AND INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). 1 VENTRICULAR FIBRILLATION (VF), 8 NOISES WITH V-V OVERSENSING AND 5 "LEAD FAILURE PREDICTOR" EPISODES OF LESS THAN 220 MS CYCLE LENGTH ARE RECORDED BETWEEN (B)(6) 2013. 265 LIFETIME V-SIC OCCUR SINCE (B)(6) 2013. LEAD INTEGRITY ALERT (LIA) TRIGGERED ON (B)(6) 2013 DUE TO MEETING THE CONDITIONS FOR NON-SUSTAINED TACHYCARDIA AND V-SIC. MAXIMUM V PACE IMPEDANCE RISES FROM AN APPROXIMATE BASELINE OF 500 OHMS TO GREATER THAN 4000 OHMS ON (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: DTBB1D1 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, IMPLANTED: (B)(6) 2013; 5076-52 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2008; 419488 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT AND LEFT VENTRICULAR LEAD THRESHOLDS WERE ELEVATED WHEN CONNECTED TO THE NEW DEVICE DURING THE DEVICE CHANGE OUT PROCEDURE. AFTER MULTIPLE ATTEMPTS TO RE-SEAT THE LEADS IN THE DEVICE HEADER AND RETESTING THE LEADS, ACCEPTABLE THRESHOLDS WERE ULTIMATELY OBTAINED WITH APPROPRIATE IMPEDANCE MEASUREMENTS. IT WAS NOTED THE PULSE WIDTH HAD INCREASED WITH THE SAME AMPLITUDE. TWO DAYS POST IMPLANT THE DEVICE WAS TONING DUE TO HIGH IMPEDANCE OF THE PACE/SENSE (P/S) PORTION OF THE RIGHT VENTRICULAR (RV) LEAD. THE P/S PORTION OF THE RV LEAD ALSO HAD ELEVATED THRESHOLDS, LOSS OF CAPTURE, AND NOISE. IT WAS ALSO NOTED THAT THERE WAS DIAPHRAGMATIC STIMULATION. THE RV PACE/SENSE IMPEDANCE ALERT WAS TURNED OFF AND THE RV PACING THRESHOLD WAS ADJUSTED TO CAPTURE. A REVISION PROCEDURE WAS SCHEDULED. AT THE PROCEDURE THE X-RAY SHOWED THAT THE RV PACE/SENSE PIN HAD RETRACTED INTO THE HEADER BLOCK. DUE TO THE SET SCREW ISSUE ON THE DEVICE AT IMPLANT, THE PHYSICIAN DID NOT TRUST THE SET SCREW TO HOLD. THEREFORE, THE DEVICE WAS EXPLANTED AND REPLACED. THE LEADS REMAIN 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
    641950 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention