BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2201969 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03851
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 1, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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): THE DEVICE HAD GONE THROUGH AT LEAST FOUR POWER ON RESETS (PORS) BETWEEN (B)(6) 2011. AFTER PRELIMINARY ANALYSIS WAS COMPLETED, THE DEVICE LOST TELEMETRY AND FUNCTION. THE DEVICE OPERATED UNDER HIGHER THAN NORMAL CURRENT DRAIN ON AN EXTERNAL SUPPLY. THE RESIDUAL VOLTAGE AND IMPEDANCE INDICATED THAT THE BATTERY WAS NOT INTERNALLY SHORTED. THE CHARGE CIRCUIT PROBLEM WAS LINKED TO A SHORTED LOW SIDE HIGH VOLTAGE CAPACITOR. THIS WOULD RENDER THE DEVICE UNABLE TO CHARGE THE HIGH VOLTAGE CAPACITORS TO DELIVER TACHYCARDIA THERAPY, AND WOULD HAVE LIKELY CONTRIBUTED TO PREMATURE BATTERY DEPLETION AND POR EVENTS THROUGH REPEATED UNSUCCESSFUL CHARGE ATTEMPTS. ARC MARKS AT THE HIGH POWER CAPACITOR ASSEMBLY TERMINALS INDICATE ARCING BETWEEN THE TERMINALS AS THE CAUSE OF THE SHORT. THE DEVICE WAS NOTED TO HAVE A HOLE IN THE TITANIUM CAN, WITH NO EXPLANATION AS TO WHEN OR HOW THE HOLE OCCURRED, AND THE AREA SURROUNDING THE HOLE HAD GRIND MARKS. THE HOLE AND GRIND MARKS WERE NOT FOUND TO BE DIRECTLY ASSOCIATED WITH ANY OF THE OBSERVED FAILURE CONDITIONS; HOWEVER, THE HOLE WOULD HAVE CHANGED THE ATMOSPHERE WITHIN THE CAN LEADING TO A LOWERED AIR-GAP RESISTANCE AND INCREASED CHANCE OF ARCING. A HIGH CURRENT DRAIN CONDITION THAT WOULD BE ASSOCIATED WITH EARLY BATTERY DEPLETION WAS NOT OBSERVED, AND NO ABNORMAL POR EVENTS WERE NOTED. THE ANALYSIS WAS STOPPED AT THIS POINT WITH THE REPORTED HIGH CURRENT DRAIN AND POR EVENTS CONDITIONS UNCONFIRMED.

    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): THE DEVICE HAD GONE THROUGH AT LEAST FOUR POWER ON RESETS (PORS) BETWEEN (B)(6) 2011. AFTER PRELIMINARY ANALYSIS WAS COMPLETED, THE DEVICE LOST TELEMETRY AND FUNCTION. THE DEVICE OPERATED UNDER HIGHER THAN NORMAL CURRENT DRAIN ON AN EXTERNAL SUPPLY. THE RESIDUAL VOLTAGE AND IMPEDANCE INDICATED THAT THE BATTERY WAS NOT INTERNALLY SHORTED. THE CHARGE CIRCUIT PROBLEM WAS LINKED TO A SHORTED LOW SIDE HIGH VOLTAGE CAPACITOR. THIS WOULD RENDER THE DEVICE UNABLE TO CHARGE THE HIGH VOLTAGE CAPACITORS TO DELIVER TACHYCARDIA THERAPY, AND WOULD HAVE LIKELY CONTRIBUTED TO PREMATURE BATTERY DEPLETION AND POR EVENTS THROUGH REPEATED UNSUCCESSFUL CHARGE ATTEMPTS. ARC MARKS AT THE HIGH POWER CAPACITOR ASSEMBLY TERMINALS INDICATE ARCING BETWEEN THE TERMINALS AS THE CAUSE OF THE SHORT. THE DEVICE WAS NOTED TO HAVE A HOLE IN THE TITANIUM CAN, WITH NO EXPLANATION AS TO WHEN OR HOW THE HOLE OCCURRED, AND THE AREA SURROUNDING THE HOLE HAD GRIND MARKS. THE HOLE AND GRIND MARKS WERE NOT FOUND TO BE DIRECTLY ASSOCIATED WITH ANY OF THE OBSERVED FAILURE CONDITIONS; HOWEVER, THE HOLE WOULD HAVE CHANGED THE ATMOSPHERE WITHIN THE CAN LEADING TO A LOWERED AIR-GAP RESISTANCE AND INCREASED CHANCE OF ARCING. A HIGH CURRENT DRAIN CONDITION THAT WOULD BE ASSOCIATED WITH EARLY BATTERY DEPLETION WAS NOT OBSERVED, AND NO ABNORMAL POR EVENTS WERE NOTED. THE ANALYSIS WAS STOPPED AT THIS POINT WITH THE REPORTED HIGH CURRENT DRAIN AND POR EVENTS CONDITIONS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM AFTER RECEIVING TWO SHOCKS. THE PATIENT HAD HEARD A POPPING OR CRACK PRIOR TO THE SHOCKS. FOLLOW-UP COULD NOT DETERMINE WHETHER THE SHOCKS WERE APPROPRIATE OR NOT. IT WAS LATER NOTED THAT THE DEVICE EXPERIENCED AN ELECTRICAL RESET AND THE WIRELESS TELEMETRY WAS NO LONGER ACTIVE. IT WAS ALSO REPORTED THAT THERE WAS A CHARGE CIRCUIT TIME OUT, SENSING DIFFICULTY, AND POTENTIAL VOLTAGE REGULATOR CIRCUIT FAILURE. THE DEVICE WAS AT ERI (ELECTIVE REPLACEMENT INDICATOR) AND EXTREME PREMATURE BATTERY DEPLETION WAS NOTED. 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
    1 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD