BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT DR

    MDR report key: 2451733 · Received February 14, 2012

    Report

    Report Number
    6000144-2012-00806
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    May 27, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. 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. HIGH RESISTANCE/IMPEDANCE WAS NOTED AS ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2011, 09:00:23. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS A SPIKE INCREASE FOR MAX VENTRICULAR PACE BI IMPEDANCE FROM 513 TO 4047 OHMS PEAK BETWEEN (B)(6) 2011, THEN RETURNING TO A BASELINE OF 456 OHMS ON (B)(6) 2011. OVERSENSING WAS ALSO NOTED AS SEVEN VENTRICULAR FIBRILLATION EPISODES <=190 MS AVERAGE V-CYCLE OCCURRED BETWEEN (B)(6) 2011, 09:46:56 AND (B)(6) 2011, 16:33:05.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS T-WAVE OVERSENSING. THE DEVICE 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 PROTECTA XT DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other 4076 IMPLANTABLE PACING LEAD| 7122 COMPETITOR IMPLANTABLE PACING LEAD| 6996 IMPLANTABLE TACHY LEAD