BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 2964685 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02287
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 4, 2012
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-1172-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS SUBSEQUENTLY RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE WAS UNABLE TO CONFIRM AN ISSUE. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. IT WAS NOTED THAT THERE WERE MULTIPLE VREG MONITOR POWER ON RESET (POR) WERE RECORDED IN RAPID SUCCESSION AS THE POR RESET PARAMETERS WERE MET.

    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 MEDICAL PRODUCTS: 5076 IMPLANTABLE PACING LEAD: (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A HIGH URGENCY POWER ON RESET (POR). THE PATIENT HAD AN EPISODE OF VENTRICULAR TACHYCARDIA THAT WAS TREATED SUCCESSFULLY WITH SHOCK. PRIOR TO THE EPISODE THERE IS EVIDENCE OF SHORT CIRCUIT PROTECTION. IT IS SUSPECTED THERE IS EITHER A LEAD ISSUE OR INTERNAL DEVICE CIRCUIT ISSUE. THE ICD WAS EXPLANTED AND REPLACED AND THE RIGHT VENTRICULAR LEADS WERE CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67504 ENTRUST VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD