BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153117 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05826
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. PRODUCT EVENT SUMMARY:THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THIRTEEN VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES OF LESS THAN OR EQUAL TO 210 MS BETWEEN (B)(6) 2013 WERE RECORDED. THERE WERE FOUR VENTRICULAR FIBRILLATION (VF) OF LESS THAN OR EQUAL TO 210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2013. ONE PATIENT ALERT FOR OUT OF TOLERANCE SUB-THRESHOLD LEAD IMPEDANCE WAS RECORDED ON (B)(6) 2013. THE DAILY PACE LEAD TREND DATA SHOWED AN INCREASE FOR MAXIMUM VENTRICULAR BIPOLAR PACING IMPEDANCE OF 551 TO 4047 OHMS PEAK BETWEEN (B)(6) 2013. THERE WAS A PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2013. PRODUCT: D224DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  (B)(6) 2009; 4076 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW DAYS AFTER A RIGHT VENTRICULAR (RV) LEAD REPLACEMENT, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. NOISE AND OVERSENSING WERE DETECTED ON THE REPLACEMENT RV LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  WAS REVIEWED TO MAKE SURE THAT THERE WAS NOT A CONNECTION ISSUE SINCE DURING THE REPLACEMENT, THE PHYSICIAN INDICATED THAT THE TORQUE WRENCH "DID NOT FEEL RIGHT." THE PHYSICIAN DECIDED TO REPLACE THE ICD AND THE RV 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
    255987 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| L| R