BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA DR

    MDR report key: 3508331 · Received December 9, 2013

    Report

    Report Number
    3004209178-2013-22663
    Event Type
    Injury
    Date Received
    December 9, 2013
    Date of Event
    September 13, 2013
    Report Date
    September 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SENSING INTEGRITY COUNTER (SIC). ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. 2 VENTRICULAR FIBRILLATION (VF) AND 5 LEAD FAILURE PREDICTOR (LFP) EPISODES OF <(><<)> 220 MS V-V CYCLE ARE RECORDED BETWEEN (B)(6) 2012 AND (B)(6) 2013. 90 OF 128 LIFETIME VENTRICULAR SHORT INTERVAL COUNTS (V-SIC) OCCUR SINCE (B)(6) 2012. LEAD INTEGRITY ALERT (LIA) ON (B)(6) 2012, AND (B)(6) 2013 DUE TO MEETING THE CONDITIONS FOR NON-SUSTAINED TACHYCARDIA (NST) AND V-SIC.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT: 6940-52 IMPLANTABLE TACHY LEAD, (B)(6) 1999, 6945-65 IMPLANTABLE TACHY LEAD, (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REMOTE TRANSMISSION SHOWED NOISE AND OVERSENSING AT VERY FAST RATES IN BOTH THE ATRIAL AND VENTRICLE CHANNELS AT THE SAME TIME, BUT THE DEFIBRILLATOR SYSTEM DOES NOT HAVE AN ATRIAL LEAD. THE DEVICE AND THE RIGHT VENTRICULAR (RV) LEADS 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
    638741 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R