BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2952687 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00667
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 26, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. (B)(4).

    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 REVEALED THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE WAS OUT OF RANGE, UNDEFINED. THE RV PACE IMPEDANCE WAS STEADY AROUND 1000 OHMS PRIOR TO (B)(6) 2000 OHMS ON (B)(6)VARIES BETWEEN 1000 AND GREATER THAN 3000 BETWEEN THE (B)(6) 2012. ALSO THERE WAS OVERSENSING NON-PHYSIOLOGICAL/SHORT INTERVAL COUNTS (SIC). THERE WAS NOISE AND OVERSENSING APPARENT ON EGM AND INTERVAL PLOTS. AT LEAST 51 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES RECORDED ON (B)(6) 2012 WITH V-V INTERVALS LESS THAN 210MS. THERE WAS 231 EPISODES RECORD (B)(6), 242 RECORDED (B)(6). ALSO THERE WAS 21830 V-SICS SINCE LAST SESSION, AVERAGE OF 6814 V-SIC/DAY. ALSO, THERE WAS AN UNEXPECTED SHOCK THERAPY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FROM THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD HAD A SUDDEN INCREASE IN IMPEDANCE TO GREATER THAN 2500 OHMS AND NOISE. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56220 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R