BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 2126679 · Received June 15, 2011

    Report

    Report Number
    6000144-2011-02780
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    March 21, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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) AND (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. POR FOR CRITICAL RAM PARITY ERROR (B)(6) 2010 20:52:32. PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2010 20:52:32. PROGRAMMER DATA SHOWS LEAD INTEGRITY ALERT TRIGGERED ON (B)(6) 2011 14:58:02. PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2011 14:58:02. VENTRICULAR NON-SUSTAINED TACHYCARDIA <=170 MS AVERAGE V-CYCLE ON (B)(6) 2011 AT 14:58:08 AND 21:44:58. VENTRICULAR SHORT INTERVAL COUNT V-SIC=145.2 COUNTS AVG/DAY, IN 3.06 DAYS, BETWEEN (B)(6) 2011 14:54:21 AND (B)(6) 2011 16:16:30.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS T-WAVE OVERSENSING ON THE RIGHT VENTRICULAR LEAD. IT WAS THOUGHT THAT THERE MIGHT BE A LEAD FRACTURE. THE LEAD SENSITIVITY WAS REPROGRAMMED TO ELIMINATE THE OVERSENSING. UPON REVIEW OF SAVE-TO-DISK INFORMATION THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THE DEVICE AND LEAD ARE STILL 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 ENTRUST VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R