BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2964609 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01526
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 5, 2012
    Report Date
    April 25, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. CONCOMITANT CONTINUED: 5076 IMPLANTABLE PACING LEAD (B)(6) 2003. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT AND CLOSING OF POCKET, THE SUPERIOR VENA CAVA (SVC) PORTION OF THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE MEASURED NONE. AFTER TAKING A SECOND IMPEDANCE MEASUREMENT, THE IMPEDANCE WAS HIGH. FOLLOW UP CONFIRMED THE SVC PORTION OF THE LEAD WAS FRACTURED. A DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED AS A SINGLE COIL LEAD WITH SUCCESS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THE ELECTROPHYSIOLOGIST WAS CONCERNED ABOUT FRACTURE AND INABILITY OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO DELIVER THERAPY IF RV COIL WAS FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67119 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| R