BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3153208 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05861
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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. 5076-52 IMPLANTABLE PACING LEAD, (B)(6) 2007. (B)(4). EVALUATION SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION, BUT WE DID RECEIVED PERFORMANCE DATA AND HAVE ANALYZED THE DATA. NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH THRESHOLD AND THE PHYSICIAN STATED THAT ON X-RAY, THE RV (RIGHT VENTRICULAR) LEAD APPEARED TO BE EXTERNAL OF THE RIGHT VENTRICULAR CHAMBER, A MYOCARDIAL PERFORATION. A LEAD REVISION WAS PERFORMED AND THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254859 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Hospitalization| L| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR