BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2953322 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01067
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 12, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. COSMETIC ENVIRONMENTAL STRESS CRACKING OF THE OVERLAY TUBING WAS NOTED AND THERE WAS A COSMETIC DEPRESSION FOUND ON THE INSULATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVALUATION: PERFORMANCE DATA WERE COLLECTED FROM THE DEVICE AND ANALYZED. THERE WAS ONE PATIENT ALERT FOR SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. THE DAILY PACE LEAD TREND DATA SHOWS AN ABRUPT INCREASE FOR VENTRICULAR PACING IMPEDANCE FROM 418 OHMS TO 4047 OHMS PEAK BETWEEN (B)(6) 2012. THERE WERE ALSO THREE PATIENT ALERTS FOR LEAD FAILURE PREDICTOR BETWEEN (B)(6) 2012. THERE WERE 15 VENTRICULAR NONSUSTAINED TACHYCARDIA EPISODES LESS THAN OR EQUAL TO 210MS ON (B)(6) 2012. IT WAS ALSO NOTED THERE WERE 11 VENTRICULAR FIBRILLATION EPISODES LESS THAN OR EQUAL TO 210MS ON AVERAGE VENTRICULAR CYCLE ON (B)(6) 2012. THE VENTRICULAR SHORT INTERVAL COUNT WAS 5101 COUNTS IN 7.27 DAYS BETWEEN (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD THE PATIENT ALERT TONE AND PRESENTED TO THE HOSPITAL. THE PHYSICIAN OBSERVED NO ABNORMALITIES AND THE PATIENT WENT HOME. THREE DAYS LATER, THE PATIENT WAS EXERCISING AND RECEIVED SEVERAL SHOCKS. OVERSENSING WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD AND THE SHOCKS WERE INADEQUATE. THE LEAD WAS CUT AND CAPPED AND A NEW LEAD WAS IMPLANTED. DURING THE REVISION PROCEDURE, THE LEAD WAS TESTED WHILE CONNECTED TO THE DEVICE AND ARTIFACTS WERE NOTED ON THE ELECTROGRAM (EGM). AFTER DISCONNECTING THE RV LEAD PIN FROM THE HEADER, THE LEAD WAS TESTED AGAIN AND NO ARTIFACTS WERE NOTED ON THE EGM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56892 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R