BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II DR

    MDR report key: 2134006 · Received June 20, 2011

    Report

    Report Number
    6000144-2011-03237
    Event Type
    Injury
    Date Received
    June 20, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4): PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY VOLTAGE - BATTERY DEPLETION INDICATED/ERI. TIME OF RRT IN SAVE TO DISK ON (B)(6) 2011, DEVICE RRT<=2.6251 V. ONE - PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(6) 2011. WEEKLY LOG BATTERY VOLTAGE TREND DATA SHOWS MIN (V)=2.6736 TO 2.5986 VOLTS BETWEEN (B)(6) 2011 AND (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE WAS INCONCLUSIVE. BASED ON THE DESTRUCTIVE ANALYSIS RESULTS, NO INTERNAL SHORT OCCURRED IN THE BATTERY. THE CONDITION OF THE ANODE SUGGESTS THE BATTERY SAW A HIGHER DEVICE DRAIN RATE WHICH WOULD INCREASE THE DISCHARGE OF THE LI ALONG THE EDGES AND IN THE TURNS, AS SEEN IN THIS BATTERY.

    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 WAS RETURNED AND ANALYSIS REVEALED THAT THE DEVICE MET 80% OF THE EXPECTED LONGEVITY. PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. POWER ON RESET - POWER ON RESET PARAMETERS. ONE - POR FOR DVDD AND I354 SUPPLY ON (B)(6) 2011 04:00:19. ONE - PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2011 04:00:19. BATTERY VOLTAGE - BATTERY DEPLETION INDICATED/ERI. TIME OF RRT IN SAVE TO DISK ON (B)(6) 2011, DEVICE RRT<=2.6251 V. ONE - PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(6) 2011. WEEKLY LOG BATTERY VOLTAGE TREND DATA SHOWS MIN (V)=2.6736 TO 2.5986 VOLTS BETWEEN (B)(6) 2011 AND (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTRICAL RESET OCCURRED DUE TO THE BATTERY VOLTAGE DROPPING SUDDENLY. THE DEVICE WAS REMOVED AND ANOTHER WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL, INC. D284DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD