BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2952569 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00622
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: PERFORMANCE DATA WAS COLLECTED AND ANALYZED. HIGH RESISTANCE/IMPEDANCE WAS NOTED AS ONE PATIENT ALERT FOR RV PACE LEAD IMPEDANCE WAS GREATER THAN 3000 OHMS ON (B)(4) 2012 03:00:04. THE WEEKLY PACE LEAD TREND DATA SHOWS AN ABRUPT INCREASE FOR MAX V PACE FROM 632 TO 14800 OHMS PEAK BETWEEN (B)(4) 2012 AND (B)(4) 2012. OVERSENSING WAS NOTED AS 50 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODE <(><<)>=190 MS OCCURRED BETWEEN (B)(4) 2012 09:35:20 AND (B)(4) 2012 06:40:12. INTERFERENCE/NOISE WAS ALSO NOTED AS VENTRICULAR SHORT INTERVAL COUNT WAS 242 COUNTS, IN 3.71 DAYS, BETWEEN (B)(4) 2012 16:11:35 TO (B)(4) 2012 09:10:37. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING AND HIGH IMPEDANCE ON THE RIGHT VENTRICULAR LEAD WHICH TRIGGERED A PATIENT ALERT. THE LEAD WAS THOUGHT TO BE FRACTURED. THE PATIENT WAS NOTED TO BE A BIKER WHO OFTEN CARRIED A HEAVY BACKPACK. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING AND HIGH IMPEDANCE ON THE RIGHT VENTRICULAR LEAD WHICH TRIGGERED A PATIENT ALERT. THE LEAD WAS THOUGHT TO BE FRACTURED. THE PATIENT WAS NOTED TO BE A BIKER WHO OFTEN CARRIED A HEAVY BACKPACK. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56865 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD