BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA S DR

    MDR report key: 3862208 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11105
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CONCOMITANT PRODUCTS: PRODUCT ID 694758 LEAD, IMPLANTED: (B)(6) 2008; PRODUCT ID 5076-45 LEAD, IMPLANTED: (B)(6) 2003; 5076-35 LEAD, IMPLANTED: (B)(6) 2003; 6996SQ58 LEAD X2, IMPLANTED: (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED DURING THE ANALYSIS OF THE RETURNED DEVICE THE FAILURE ON THE HYBRID DISAPPEARED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER HOOKING UP THE CHRONIC LEADS TO THE NEW DEVICE, IT WAS OBSERVED THAT THE PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) CHANNEL WAS READING AT 0 OHMS. AFTER REINSERTION OF ALL LEADS IN THEIR PORTS AND VERIFYING THAT THEIR RESPECTIVE PINS WERE PAST THEIR SET SCREWS, RE-MEASURING THE IMPEDANCES YIELDED THE HIGHEST VALUE OF 19 OHMS. TESTING OF THE RV LEAD THROUGH THE ANALYZER YIELDED STABLE PACING IMPEDANCES WITH LOW PACING THRESHOLD AND GOOD SENSING. AGAIN, HOOKING BACK UP TO THE DEVICE STILL GAVE ANOMALOUS IMPEDANCE READINGS OF 0 AND 19 OHMS. CHANGING THE PACING POLARITY TO TIP TO COIL STILL GAVE ANOMALOUS AND UNSTABLE IMPEDANCE READINGS. THE DEVICE WAS ATTEMPTED AND NOT USED. ANOTHER DEVICE WAS USED. INSERTION OF ALL LEADS TO THE NEW DEVICE AND SUBSEQUENT TESTING YIELDED STABLE IMPEDANCES ON ALL CHANNELS, WITH RV PACING IMPEDANCE BEING ROCK SOLID. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342694 EVERA S DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DDBC3D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR 672625 ADAPTOR