BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2812568 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16200
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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. THERE WAS AN IMPEDANCE INCREASE. THE WEEKLY PACE LEAD MEASUREMENT LOG DATA SHOW VARIOUS SPIKE INCREASES FOR MAXIMUM VENTRICULAR PACING EQUAL TO 456 TO 2048 OHMS RANGE BETWEEN (B)(6) 2011 AND (B)(6) 2012. THERE WAS OVERSENSING WITH NINE VENTRICULAR FIBRILLATION EPISODES LESS THAN OR EQUAL 210 MILLISECONDS PER AVERAGE VENTRICULAR CYCLE BETWEEN (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD VARYING AND HIGH IMPEDANCE, NOISE AND OVERSENSING. THE LEAD WAS CAPPED AND REPLACED. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6943

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB