BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3071688 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05232
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED HIGH IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) COIL. ALSO NOTED WERE TWO PATIENT ALERTS FOR OUT OF RANGE LEAD IMPEDANCE ON (B)(4) 2011. WEEKLY HIGH VOLTAGE LEAD TREND DATA SHOW VARIOUS SPIKE INCREASES FOR THE SVC DEFIBRILLATION IMPEDANCE FROM 69 TO 7368 OHMS PEAK BETWEEN (B)(4) 2011 AND (B)(4) 2013. (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR 2008 (B)(6); 5076 IMPLANTABLE PACING LEAD 2004 (B)(6); 4193 IMPLANTABLE PACING LEAD 2004 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) COIL AND SVC COIL FRACTURE WAS SUSPECTED. VISIBLE NOISE WAS NOTED ON THE VENTRICULAR ELECTROGRAM (VEGM) WHEN THE LEAD WAS TESTED THROUGH THE ANALYZER. THE SVC COIL WAS CAPPED AND A PIN-PLUG WAS PLACED IN THE SVC PORT OF THE DEVICE. THE REST OF THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171556 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R