BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1793983 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07244
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED, AND VARYING RESISTANCE/IMPEDANCE WAS OBSERVED. THE MAX RV IMPEDANCE MEASUREMENT VARIED OVER THE DURATION OF THE RECORD WITH A RANGE FROM 696 - 1392 OHMS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED, AND VARYING RESISTANCE/IMPEDANCE WAS OBSERVED. THE MAX RV IMPEDANCE MEASUREMENT VARIED OVER THE DURATION OF THE RECORD WITH A RANGE FROM 696 - 1392 OHMS. (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. DEVICE MEETS EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV PACING IMPEDANCE WAS VARYING FROM 600 OHMS UP TO 1300 OHMS ("SPIKING") THROUGHOUT THE LONG TERM TREND. THE COMPANY TECHNICAL REPRESENTATIVE SUGGESTED THE DATA ARE CONSISTENT WITH EITHER LEAD FRACTURE OR A CONNECTOR ISSUE. THE LEAD AND DEVICE REMAIN 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 SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD