BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2812000 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17145
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. EVALUATION SUMMARY (B)(4) - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE BATTERY VOLTAGE INDICATED PRE/APPROACHING ELECTIVE REPLACEMENT INDICATOR. THE WEEKLY BATTERY VOLTAGE TREND DATA IN SAVE TO DISK FILE (B)(4) SHOWS MINIMUM BATTERY VOLTAGE EQUAL TO 2.944 TO 2.814 VOLTS BETWEEN (B)(6) 2012 AND (B)(6) 2012 WHICH IS BEFORE DEVICE RECOMMENDED REPLACEMENT TIME LESS THAN OR EQUAL TO 2.6251 VOLTS. (B)(4) - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS OVERSENSING WITH ON VENTRICULAR FIBRILLATION EPISODE EQUAL TO 190 MILLISECONDS PER AVERAGE VENTRICULAR CYCLE ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LONGEVITY OF THE DEVICE WAS QUESTIONED BY THE CLINICIAN. IT WAS THOUGHT THAT THE DEVICE LONGEVITY SHOULD BE LONGER. THE DEVICE IS STILL IN USE. THE VENTRICULAR LEAD TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THE LEAD IS STILL IN USE. 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 QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other 5076 IMPLANTABLE PACING LEAD