BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 3992111 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14898
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 694765, LEAD, IMPLANTED: (B)(6) 2009; 419688, LEAD, IMPLANTED: (B)(6) 2009. (B)(4).

    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 THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED UNEXPECTED LONGEVITY. THE BATTERY HAD COMPLETELY DEPLETED AND WAS UNABLE TO BE INTERROGATED. THE PHYSICIAN STATED THAT THE LEFT VENTRICULAR (LV) LEAD HAD BEEN PROGRAMMED VERY HIGH. THE PATIENT LOST CONSCIOUSNESS AND WAS IN ASYSTOLE, AND HAD TO BE LIFE FLIGHTED TO THE HOSPITAL. THE PATIENT WAS TRANSCUTANEOUSLY PACED AND INTUBATED. A TEMPORARY TRANSVENOUS PACEMAKER WAS INITIALLY PLACED UNTIL THE ICD COULD BE EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AT THE NEXT MORNING POST-OP CHECK THE PATIENT WAS EXTUBATED AND WAS SITTING UP IN THE CHAIR ALERT AND O RIENTED. THERE WERE NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470312 PROTECTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| L| R 4135, LEAD