BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1861757 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10115
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 8, 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
    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. HIGHEST WEEKLY TREND FOR RIGHT VENTRICULAR PACE IMPEDANCE IS 1296 FROM THE WEEK OF (B)(4) 2010. A RECENT DAILY VALUE OF 1680 OHMS WAS RECORDED ON (B)(4) 2010. THE WEEKLY VALUE CORRESPONDING TO THAT DAILY VALUE HAS NOT YET BEEN ADDED TO THE WEEKLY TREND. NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ASKU

    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 PATIENT CAME INTO THE OFFICE DUE TO PATIENT ALERT TONES FOR OUT OF RANGE IMPEDANCE. THE CALLER STATED THAT THE PACING LEAD IMPEDANCE REPORTED AN OBSERVATION TEXT AS 1680 OHMS ALTHOUGH THE LEAD IMPEDANCE TRENDS ONLY SHOWED HIGHEST AS 1296 OHMS. IT WAS FURTHER REPORTED THAT CROSS TALK SEEMED TO BE OCCURRING WITH THE LEAD. 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 REPORTED THAT THE PATIENT CAME INTO THE OFFICE DUE TO PATIENT ALERT TONES FOR OUT OF RANGE IMPEDANCE. THE CALLER STATED THAT THE PACING LEAD IMPEDANCE REPORTED AN OBSERVATION TEXT AS 1680 OHMS ALTHOUGH THE LEAD IMPEDANCE TRENDS ONLY SHOWED HIGHEST AS 1296 OHMS. THE 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 SECURE ASKU LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4968 IMPLANTABLE PACING LEAD| 4968 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 4968 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD