BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1669402 · Received April 29, 2010

    Report

    Report Number
    6000144-2010-01565
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    April 19, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    Z-0126-2010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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) ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. (B) (4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED DURING DEVICE CHANGEOUT AND PROPHYLACTIC LEAD REVISION. DURING THE LASER LEAD EXTRACTION, THE PATIENT "CODED AND DIED." FOLLOW UP WITH MANUFACTURER'S REPRESENTATIVE REPORTED THE CAUSE OF DEATH IS UNKNOWN. THE PATIENT DID BECOME HEMODYNAMICALLY UNSTABLE DURING THE DEVICE CHANGEOUT AND DID NOT MAKE IT TO SURGERY. THERE ARE NO DEVICE ALLEGATIONS AS RELATES TO THE PATIENT DEATH.

    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 60 YR Death 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD