BEUDAMED
    FDA Adverse Event Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1863393 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-11338
    Date Received
    October 9, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    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.

    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. ANALYSIS INDICATES HIGH RESISTANCE/IMPEDANCE. THE MAXIMUM RIGHT VENTRICULAR (RV) PACE LEAD IMPEDANCE INITIATED OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE PATIENT ALERTS ON (B)(6) 2009, (B)(6) 2009, AND (B)(6) 2010. IMPEDANCE VALUES ON THESE THREE OCCASIONS WERE 1056 OHMS, 1232 OHMS AND 1840 OHMS RESPECTIVELY. ADDITIONAL ANALYSIS SHOWED VARYING RESISTANCE/IMPEDANCE. THE MAXIMUM RV PACE LEAD IMPEDANCE VARIES BETWEEN AN APPROXIMATE BASELINE OF 420 OHMS TO A HIGH OF 1840 OHMS BETWEEN THE WEEKS OF (B)(6) 2009 AND (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED VARYING IMPEDANCE MEASUREMENTS FOR "NUMEROUS MONTHS". ON ONE OCCASION, THE MEASUREMENT WAS HIGH. THE PHYSICIAN QUESTIONED WHETHER THERE MIGHT BE A POTENTIAL FRACTURE ON THE LEAD. AN X-RAY SHOWED THE PIN TO BE FULLY INSERTED. THE LEAD REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED VARYING IMPEDANCE MEASUREMENTS FOR "NUMEROUS MONTHS". ON ONE OCCASION, THE MEASUREMENT WAS HIGH. THE PHYSICIAN QUESTIONED WHETHER THERE MIGHT BE A POTENTIAL FRACTURE ON THE LEAD. AN X-RAY SHOWED THE PIN TO BE FULLY INSERTED. THE LEAD REMAINS IMPLANTED. 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 Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB