BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 1863114 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05015
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    July 19, 2010
    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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES WERE FOUND. NO ISSUES WERE OBSERVED THAT WOULD RELATE TO THE REASON FOR THIS REPORT.

    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 DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES WERE FOUND. NO ISSUES WERE OBSERVED THAT WOULD RELATE TO THE REASON FOR THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT THEIR IMPLANTED DEFIBRILLATOR HAS BEEN WARM TO THE TOUCH. THE DEVICE IS STILL IN USE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT THEIR IMPLANTED DEFIBRILLATOR HAS BEEN WARM TO THE TOUCH. THE DEVICE IS STILL IN USE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE PATIENT WAS EXPERIENCING CHEST PAIN AND A HIGH HEART RATE AND WENT TO THE HOSPITAL. THE PATIENT'S SON WAS QUESTIONING WHY "THE SYSTEM DID NOT KICK IN." THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN 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 67 YR Hospitalization| O| R 6947 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD| 4574 IMPLANTABLE PACING LEAD| 4574 IMPLANTABLE PACING LEAD