BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2864858 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17548
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 FOUND THERE WAS AN OUT OF TOLERANCE SUB THRESHOLD LEAD IMPEDANCE ALERT ON (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. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD, (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE REMOTE MONITORING TRANSMISSION SHOWED THE RIGHT VENTRICULAR (RV) LEAD HAD AN ABNORMAL INCREASE IN RV COIL IMPEDANCE CAUSING A PATIENT ALERT TO TRIGGER. THE IMPEDANCE HAD STARTED TO SLOWLY RISE FROM ABOUT 32 OHMS UP TO 75 OHMS AND THEN SPIKED IN ONE DAY TO GREATER THAN 200 OHMS. A SURGICAL INTERVENTION WAS DONE TO CHECK THE LEAD AND WHEN THE POCKET WAS OPENED EVERYTHING LOOKED WELL AND THE DOCTOR DID A TUG TEST ON ALL THE LEAD CONNECTIONS AND NOTHING MOVED. THE RV LEAD IMPEDANCES WERE CHECKED WITH THE DEVICE AGAIN AND THE RV COIL WAS 120 OHMS AND THE RV PACING IMPEDANCE WAS 400 OHMS. THE RV LEAD WAS CHECKED TWICE BY BEING DISCONNECTED FROM THE DEVICE, TESTED WITH THE ANALYZER AND THEN RECONNECTED TO THE DEVICE AND BOTH TIMES ALL THE IMPEDANCE MEASUREMENTS WERE IN A NORMAL RANGE AND STABLE. ALSO, THE REPEATED IMPEDANCE MEASUREMENTS WHILE MANIPULATING THE PATIENTS SHOULDER AND STILL THE IMPEDANCE WAS NORMAL. IT WAS ELECTED THAT SINCE THE ABNORMAL IMPEDANCE MEASUREMENTS COULD NOT BE REPRODUCED WITH TESTING TO LEAVE THE RV LEAD 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6932

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD)