BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA CRT-D

    MDR report key: 2457424 · Received February 16, 2012

    Report

    Report Number
    6000094-2012-00433
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    December 1, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. EVALUATION SUMMARY: (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA THAT COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ONE - PATIENT ALERT FOR LEAD FAILURE PREDICTOR (LFP) ON (B)(4)-2011 13:57:12. FOUR - LFP HIGH RATE-NS <= 205 MS AVERAGE V-CYCLE ON (B)(4)-2011 IN THE TIMEFRAME BETWEEN 12:47:17 AND 14:27:42. VENTRICULAR SHORT INTERVAL COUNT V-SIC=2.6 COUNTS AVG/DAY, IN 12.98 DAYS, BETWEEN (B)(4)-2011 12:15:22 AND (B)(4)-2011 11:39:37.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST-IMPLANT, NST (NON-SUSTAINED TACHYCARDIA) EPISODES WERE RECORDED. THE DEVICE AND LEAD REMAIN 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 CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D334TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other 5594 IMPLANTABLE PACING LEAD| 4396 IMPLANTABLE PACING LEAD