BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST

    MDR report key: 2231920 · Received September 1, 2011

    Report

    Report Number
    2647346-2011-01145
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    September 26, 2019
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    Z-1172-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE AND LEAD WERE REMOVED AND REPLACED. THE DEVICE HAD SHOWN MULTIPLE NOISE EPISODES, AND THE LEAD WAS APPARENTLY FRACTURED. ANALYSIS OF THE DEVICE AND LEAD ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. 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. SENSING - OVERSENSING 2 - VENTRICULAR NST=210 MS AVERAGE V-CYCLE ON (B)(6) 2010 18:47:26 AND (B)(6) 2011 19:16:30. VF<=210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2008 11:29:43 AND (B)(6) 2011 22:03:24. SENSING - INTERFERENCE/NOISE VENTRICULAR SHORT INTERVAL COUNT V-SIC=72.7 COUNTS AVG/DAY, IN 111.62 DAYS, BETWEEN (B)(6) 2011 19:21:09 AND (B)(6) 2011 10:17:41.

    Additional Manufacturer Narrative · 1

    CORRECTED: PREVIOUSLY SUBMITTED FOLLOW-UP REPORT #003 SHOULD HAVE BEEN SEQUENCED #001, SO THIS REPORT IS BEING SUBMITTED AS A PLACEHOLDER WITH THE SEQUENCE #001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED: PREVIOUSLY SUBMITTED FOLLOW-UP REPORT #004 SHOULD HAVE BEEN SEQUENCED #002, SO THIS REPORT IS BEING SUBMITTED AS A PLACEHOLDER WITH THE SEQUENCE #002. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD ALERT. THE SHORT INTERVAL COUNT IS NOW GREATER THAN 8000 AND THERE IS AN INCREASE IN IMPEDANCE FROM 400'S OHMS TO 600'S OHMS. THE LEAD IS 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MDT PUERTO RICO OPERATIONS CO, MED REL D154VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Hospitalization| R| O