BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2952561 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00613
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 18, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. (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 THERE WAS OVERSENSING WITH NON-PHYSIOLOGICAL SHORT INTERVAL COUNTS (SIC) WITH 1115 LIFETIME COUNTS OF VENTRICULAR SIC ARE RECORDED BEGINNING (B)(6) 2012. THERE WAS AN ALERT FOR UNDEFINED RESISTANCE WITH OUT OF THRESHOLD SUBTHRESHOLD LEAD IMPEDANCE RECORDING AN ALERT ON (B)(6) 2012. ALSO, THERE WAS SENSING OF THIRTEEN NON-SUSTAINED TACHYCARDIA EPISODES OF LESS THAN 220MS V-V CYCLE WERE RECORDED ON (B)(6) 2012.

    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 SHOCKS FROM THE RIGHT VENTRICULAR (RV) LEAD DUE TO THE PACE/SENSE PORTION HAVING MANY NON-SUSTAINED TACHYCARDIA EPISODES WHICH EXHIBITED NOISE. THERE WAS ALSO AN ELEVATED SHORT INTERVAL COUNTS (SIC). IT WAS NOTED THE IMPEDANCE WAS WITHIN NORMAL LIMITS. IT WAS ALSO REPORTED THAT PATIENT ARM MOVEMENTS DURING TROUBLESHOOTING PRODUCED NOISE ON THE RV PACE/SENSE VECTOR THAT WERE NOT SENSED AND THERE WAS AN ALERT FOR ALL EPISODES EXHAUSTED IN AN EPISODE. THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED AND REPLACED, AND THE HIGH VOLTAGE PORTION OF 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
    56861 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945-65

    Patients

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