BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2952586 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01753
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    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. (B)(4). CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2005; 6949 IMPLANTABLE TACHY LEAD (B)(6) 2005.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THERE WAS "COMPLICATIONS" GOING INTO THE GROCERY STORE AND THE PATIENT IS UNABLE TO GO NEAR ANY TYPE OF REFRIGERATION. WHEN THE PATIENT IS WITHIN 20-25 FEET OF A REFRIGERATION UNIT THE PATIENT STARTS TO FEEL "FUNNY", HAS GOTTEN "KNOCKED OUT", BECOMES WEAK, TREMBLES, SHAKES, LOST CONSCIOUSNESS AND ONE TIME WAS FROZEN TO THE GROCERY CART HANDLE. THE PATIENT ALSO REPORTED THAT THEIR "HEART WENT CRAZY" AND THE PATIENT FELL DOWN RECENTLY. AFTER COMING HOME FROM THE STORE, THE PATIENT WAS "HIT TWICE" WHILE LYING DOWN WITH A TOTAL OF FOURTEEN "SHOCKS". THE PATIENT WAS TAKEN BY AMBULANCE TO THE HOSPITAL WHERE THE PATIENT UNDERSTOOD THAT THE "SHOCKS" MAY HAVE BEEN RELATED TO GETTING A TOUCH OF PNEUMONIA. THE DOCTOR WORKED WITH MEDICATIONS AND THE CARDIOLOGIST AND IT WAS CONFIRMED THAT THE PATIENT HAD RECEIVED AT LEAST 10 SHOCKS. NO PROGRAMMING ADJUSTMENTS WERE MADE TO THE DEVICE AND THE PATIENT UNDERSTANDS THERE IS NOTHING WRONG WITH THE DEVICE. THE PATIENT HAS BEEN HOSPITALIZED FOUR TIMES IN FIVE WEEKS. FOLLOW UP WAS CONDUCTED WITH THE PATIENT'S DOCTOR'S OFFICE BUT THEY WERE UNAWARE OF THE PATIENT'S EXPERIENCE. THE DEVICE AND RIGHT VENTRICULAR LEAD REMAIN 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
    57501 CONCERTO CRT-D DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO C154DWK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4194 IMPLANTABLE PACING LEAD