BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 2954387 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02404
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 26, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4): PRODUCT PERFORMANCE INFORMATION WAS RECEIVED, ANALYZED, AND THE DEVICE WAS PRE/APPROACHING ELECTIVE REPLACEMENT INDICATOR. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOW MINIMUM BATTERY WAS 3.0 TO 2.76 VOLTS BETWEEN (B)(6) 2012 IS BEFORE DEVICE RECOMMENDED REPLACEMENT TIME AT <(><<)>=2.61 VOLTS. OVERSENSING WAS NOTED. FIFTEEN VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES <(><<)>=210 MS OCCURRED BETWEEN (B)(6) 2012. LEAD INTEGRITY ALERT WAS TRIGGERED. PROGRAMMER DATA SHOW ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR OCCURRED ON (B)(6) 2012. ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2012. HIGH RESISTANCE/IMPEDANCE WAS ALSO NOTED AS ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2012. THE DAILY PACE LEAD TREND DATA SHOW AN ABRUPT INCREASE FOR RIGHT VENTRICULAR PACE WAS 472 TO INFINITY OHMS PEAK BETWEEN (B)(6) 2012. INTERFERENCE/NOISE WAS ALSO NOTED AS THE VENTRICULAR SHORT INTERVAL COUNT WAS 1479 COUNTS IN 40.74 DAYS BETWEEN (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES WERE FOUND. ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY INDICATOR SIGNIFYING THAT IT THE TIME IS APPROACHING FOR DEVICE REPLACEMENT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) AFTER RECEIVING INAPPROPRIATE SHOCKS DUE TO A FRACTURED RIGHTVENTRICULAR (RV) LEAD. THE LEAD HAD NO CAPTURE AT MAXIMUM OUTPUTS, HIGH IMPEDANCE, OVERSENSING, AND NOISE. THE LEAD WAS CAPPED ANDREPLACED. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD POSSIBLE PREMATURE BATTERY DEPLETION OR HEADER BLOCK ISSUE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD POSSIBLE PREMATURE BATTERY DEPLETION OR HEADER BLOCK ISSUE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59671 ENTRUST VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD