BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2811412 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17104
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS; HOWEVER WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE. PATIENT ALERT FOR LEAD FAILURE PREDICTOR TRIGGERED ON (B)(6) 2012. THERE WERE VENTRICULAR SHORT INTERVAL COUNTS (V-SIC) OF 5458 COUNTS IN 179.8 DAY BETWEEN (B)(6) 2011 AND (B)(6) 2012. THE WEEKLY PACING LEAD IMPEDANCE TREND DATA SHOWED VARIOUS SPIKE INCREASES FOR MAXIMUM VENTRICULAR BIPOLAR IMPEDANCE OF 779 TO 2185 OHMS PEAK BETWEEN (B)(6) 2012. LEAD FAILURE PREDICTOR HIGH RATE OF NON-SUSTAINED OF LESSTHAN OR EQUAL TO 207 MS AVERAGE V-CYCLE ON (B)(6) 2012. ONE VENTRICULAR FIBRILLATION (VF) AT 150 MS AVERAGE V-CYCLE ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT WAS TRIGGERED. IT WAS ALSO REPORTED THAT THE LEAD WAS FRACTURED, HAD HIGH AND VARYING IMPEDANCE, WAS OVERSENSING AND HAD NOISE. THE LEAD WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB