BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2051227 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05513
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE - VARYING RESISTANCE/IMPEDANCE: WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOW VARYING IMPEDANCE SPIKE INCREASES FOR MAX RV PACE EQUALING 368 TO 1856 OHMS PEAK BETWEEN (B)(6) 2010 AND 20-(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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD IMPEDANCE VARIABILITY FOLLOWING GENERATOR CHANGE. THE RV LEAD REMAINS IN USE AND IS UNDER CLOSE MONITORING. IT WAS ALSO REPORTED THAT THE DEVICE WHICH WAS CONNECTED TO RV LEAD WAS MOST LIKELY THE CAUSE OF THE VARIABILITY IN IMPEDANCE DUE TO A LOOSE SETSCREW. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE WHICH REMEDIED THE ISSUE AND THE PATIENT CONTINUES TO BE MONITORED REMOTELY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD IMPEDANCE VARIABILITY FOLLOWING GENERATOR CHANGE. THE RV LEAD REMAINS IN USE AND IS UNDER CLOSE MONITORING. 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 69 YR Hospitalization| O| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD