BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2864905 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17528
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    January 31, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION; HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUB-THRESHOLD LEAD IMPEDANCE ON 2012 (B)(6) AND 2012 (B)(6). IT WAS ALSO NOTED THAT THERE WERE TWO ALERTS FOR RIGHT VENTRICULAR BIPOLAR LEAD IMPEDANCE OF 1539 OHMS ON 2012 (B)(6) AND RIGHT VENTRICULAR BIPOLAR LEAD IMPEDANCE GREATER THAN 2052 OHMS ON 2012 (B)(6).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITTANT PRODUCTS: D314DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2012, 5076 IMPLANTABLE PACING LEAD (B)(6) 2002. (B)(4). THE LEAD HAS NOT BEEN RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALERT DUE TO HIGH IMPEDANCE ON THE RIGHT VENTRICULAR LEAD. NO CHANGES HAVE BEEN MADE AND 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
    1 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR