BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2953564 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01180
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 15, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. VISUAL ANALYSIS REVEALED APPARENT EXPLANT DAMAGE. PERFORMANCE DATA WERE COLLECTED FROM THE DEVICE, SUBMITTED TO THE MANUFACTURER, AND ANALYZED. AN ALERT FOR LEAD FAILURE PREDICTOR (LFP) WAS RECORDED ON (B)(6) 2012 DUE TO MEETING THE CONDITIONS FOR NONSUSTAINED TACHYCARDIA (NST) AND THE SENSING INTEGRITY COUNTER. TWO EPISODES OF NST LESS THAN 200 MS AND TWO EPISODES OF LFP WERE RECORDED BETWEEN (B)(6) 2012. THE VENTRICULAR SENSING INTEGRITY COUNT WAS 602 SINCE THE IMPLANT DATE OF (B)(6) 2012.

    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 THE PATIENT HEARD THE LEAD ALERT. IT WAS NOTED THE LEAD THRESHOLD MEASUREMENTS HAD BEEN CHRONICALLY HIGH AND WERE INCREASING. LEAD NOISE WAS ALSO OBSERVED. A LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS PARTIALLY REMOVED WITH THE REMAINDER CAPPED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57481 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

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