BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2865071 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17653
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    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

    PRODUCT EVALUATION SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS REVEALED THE RV PACING LEAD IMPEDANCE WAS HIGH AND OUT OF RANGE. OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ALERTS ARE OBSERVED ON (B)(4) 2012 AND (B)(4) 2012. MANY MAX RV PACE IMPEDANCE WEEKLY MEASUREMENTS ARE 1000 OHMS BETWEEN THE WEEKS OF (B)(4) 2012. VARYING MAX RV PACE IMPEDANCE WEEKLY MEASUREMENTS ARE SEEN BETWEEN 520 OHMS AND 1936 OHMS BETWEEN THE WEEKS OF (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR [RV] LEAD HAS HAD VARYING AND HIGH PACING IMPEDANCE MEASUREMENTS. ISOMETRICS, POSITIONAL CHANGES, AND POCKET MANIPULATION DID NOT PRODUCE OVERSENSING. THE RV LEAD IS BEING MONITORED AND 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 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR (B)(4) IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR