BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 2051628 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01533
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. EVALUATION SUMMARY: (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SUBTHRESHOLD LEAD IMPEDANCE PATIENT ALERT IS OBSERVED ON (B)(6) 2011. THIS RISE IS SEEN AS A SPIKE IN THE VPACE IMPEDANCE TO 4047 OHMS ON THE DAILY TRENDS. THE IMPEDANCE FALLS TO 1558 OHMS ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH AND UNSTABLE IMPEDANCE, AND THERE WAS A QUESTION REGARDING FRACTURE. A CHEST X-RAY INDICATED THAT ONE OF THE CONNECTOR PINS OF THE LEAD WAS NOT FULLY SEATED IN THE CONNECTOR. THE PHYSICIAN REOPENED THE POCKET AND RESEATED THE CONNECTOR PINS OF THE LEAD. THE LEAD AND THE DEVICE ARE STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D284TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD