BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2955179 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00816
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    February 1, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4) - WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE LEAD AND HAVE ANALYZED THE DATA. THERE WERE TWO EPISODES OF NON-SUSTAINED TACHYCARDIA LESS THAN 220 MILISECONDS RECORDED ON 2012 (B)(6) AND 2012 (B)(6). THERE WERE ELEVATED EPISODES OF SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE AND DEFIBRILLATION ACTIVE IMPEDANCE OCCURRING ON THE (B)(6) 2012 OF GREATER THAN 120 TO GREATER THAN 180 OHMS. OUT OF THRESHOLD, SUBTHRESHOLD LEAD IMPEDANCE ALERT OCCURRED 2012 (B)(6). THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE OVERLAY TUBING HAD ENVIRONMENTAL STRESS CRACKING. THE OUTER INSULATION HAD A DEPRESSION.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD WARNING FOR HIGH IMPEDANCE ON THE SUPERIOR VENA CAVA COIL AND THE RIGHT VENTRICULAR COIL ON THE RIGHT VENTRICULAR LEAD. NOISE WAS ALSO VISIBLE ON THE RIGHT VENTRICULAR COIL ON ELECTROGRAM. THE LEAD WAS PARTIALLY REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59666 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC