BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2952074 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00391
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE DISTAL AND PROXIMAL CONDUCTORS OF THE LEAD DEVELOPED FRACTURES DUE TO FLEXING WHILE IN VIVO. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVENT SUMMARY: PERFORMANCE DATA WAS COLLECTED FOR THE LEAD AND ANALYZED. THE WEEKLY PACE IMPEDANCE TREND DATA SHOWS A GRADUAL INCREASE FOR MINIMUM AND MAXIMUM VENTRICULAR PACE IMPEDANCE EQUAL TO A 1064 TO 2603 OHMS RANGE BETWEEN (B)(6) 2011 AND (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. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD 2009 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A RISE IN PACING IMPEDANCE. IT WAS ALSO NOTED THAT THE PATIENT HAD LEFT ARM PAIN SINCE IMPLANT. THE PATIENT WILL BE MONITORED BY IN-OFFICE CHECKS EVERY THREE MONTHS AND 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 FURTHER REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. THE RV LEAD HAD NOISE, HIGH IMPEDANCE, AND A POTENTIAL FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57056 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIAC DEFIBRILLATOR