BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2953605 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01311
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 2, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. PRODUCT EVENT SUMMARY : THE SAVE TO DISK OF THE ASSOCIATED DEVICE WAS REVIEWED. IT REVEALED THERE WAS TWO RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERTS ON (B)(4) 2010 19:28:08 AND (B)(4) -2012 15:06:11. IN ADDITION THERE WERE TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2010 19:28:08 AND (B)(4) 2012 AND VENTRICULAR SHORT INTERVAL COUNT EQUAL TO 1165 COUNTS, IN 79.04 DAYS, BETWEEN (B)(4) 2012 14:12:51 TO (B)(4) 2012 15:06:18. ALSO NOTED TWO VENTRICULAR NON-SUSTAINED TACHYCARDIA LESS THAN OR EQUAL TO 170 MS ON (B)(4) 2012 16:49:24 AND (B)(4) 2012 15:06:10. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD 2008 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD OVERSENSING. THE RV LEAD IS BEING MONITORED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH SHORT INTERVAL COUNTS (SIC) AND POOR R WAVES. THE RV LEAD PACING AND SENSING PORTION WAS CAPPED AND REMAINS IN PLACE FOR HIGH VOLTAGE. A NEW RV LEAD WAS IMPLANTED FOR PACING AND SENSING ONLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56271 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR