BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1792286 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03198
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    May 7, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD FRACTURED, AND THE PATIENT HAD SYNCOPE. PATIENT HAD EPISODES OF ASYSTOLE DUE TO INAPPROPRIATE INHIBITION ("8-SECOND PAUSES"). LEAD INTEGRITY ALERT WAS TRIGGERED. "NO INAPPROPRIATE SHOCK" WAS REPORTED. HIGH RIGHT VENTRICULAR PACING IMPEDANCE AND OVERSENSING WAS NOTED. THE PATIENT'S SPOUSE REPORTED "THE LEAD FRACTURED AND MY HUSBAND FELL, CUT OPEN HIS HEAD AND WAS NOT FEELING WELL. TOOK HIM TO THE EMERGENCY ROOM AND FOUND HIS DEVICE WAS FAULTY". THE PATIENT'S SPOUSE ALSO REPORTED "PATIENT FELL WHEN SHOCKED" AND THAT THE PATIENT HAD A HOSPITAL STAY FOR "ANEMIA AND CONGESTIVE HEART FAILURE" THAT SHE FEELS IS RELATED TO THE DEVICE REPLACEMENT. THE LEAD AND THE DEVICE WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 5071 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| UNK IMPLANTABLE PACING LEAD