BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2953554 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01987
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    February 19, 2013
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY THE DEVICE WAS RETURNED AND ANALYZED. THE ANALYSIS OF THE HYBRID DOCUMENTED HIGH CURRENT DRAIN, APPROXIMATELY 24MA. THE CAUSE OF THE HIGH CURRENT DRAIN WAS LOCALIZED TO A LOW RESISTANCE SHORT BETWEEN DVDD, NOMINAL POTENTIAL OF 1.96V, AND VSS, GROUND. THE LOCALIZATION OF THE DVDD TO VSS SHORT WAS CONTINUED BY ISOLATING COMPONENTS CONNECTED TO DVDD FROM THE SYSTEM. TWO SHORTS WERE NOTED DURING X-RAY EVALUATION BETWEEN THE SOLDER BUMPS CONNECTING THE D273 IC TO THE HYBRID. ONE OF THE SHORTS FORMED A PATH BETWEEN DVDD AND VSS, BUMPS #12 AND #13. THIS SHORT WAS THE CAUSE OF THE HIGH CURRENT DRAIN WHICH LED TO THE EARLY EXPLANT OF THIS DEVICE FROM THE FIELD. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED, HOWEVER, THE DATA AVAILABLE WAS FROM 2012-05-04 WHERE THERE WERE NO ANOMALIES FOUND.

    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: 5076 IMPLANTABLE PACING LEAD: (B)(6) 2004. 4194 IMPLANTABLE PACING LEAD: (B)(6) 2004. (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 PATIENT WAS FEELING "CRUMMY", INCLUDING FATIGUE AND SHORTNESS OF BREATH. AT THE CLINIC THEY WERE UNABLE TO INTERROGATE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. ATTEMPTED TO INTERROGATE THE ICD WITH TWO DIFFERENT PROGRAMMERS IN TWO SEPARATE CLINIC ROOMS, TRIED A THIRD TIME WITH A DIFFERENT PROGRAMMER IN THE HOSPITAL. PLACING A MAGNET OVER THE DEVICE DID NOT INITIATE TONES FROM DEVICE. POSSIBLE EARLY BATTERY DEPLETION OR RANDOM COMPONENT FAILURE IS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55943 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6947 IMPLANTABLE TACHY LEAD