BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 1992648 · Received February 15, 2011

    Report

    Report Number
    2647346-2011-00174
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 8, 2009
    Report Date
    September 19, 2019
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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): NO ANOMALIES WERE FOUND; HOWEVER GROMMET DAMAGE WAS NOTED.

    Additional Manufacturer Narrative · 1

    CORRECTION: PREVIOUSLY SUBMITTED FOLLOW-UP REPORT #002 SHOULD HAVE BEEN SEQUENCED #001. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): NO ANOMALIES WERE FOUND; HOWEVER GROMMET DAMAGE WAS NOTED. (B)(4): THE DEVICE MET 83% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THERE WAS TRANSIENT OVERSENSING. THE POCKET WAS REOPENED AND THE CONNECTION CONFIRMED. THE LEAD CONNECTOR PIN WAS INSPECTED AND REINSERTED IN THE RV P/S PORT AND TIGHTENED DOWN, WITH OVERSENSING STILL PRESENT. A NEW DEVICE WAS USED. WHEN THE SECOND DEVICE WAS CONNECTED TO THE LEAD SYSTEM, OVERSENSING WAS AGAIN PRESENT. THE SECOND DEVICE WAS LEFT IN PLACE AND THE PATIENT MONITORED FOR A FEW DAYS TO CHECK FOR OVERSENSING, WITH NO FURTHER OVERSENSING ISSUES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A QUESTION AS TO WHY THE DEVICE LASTED ONLY 23 MONTHS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO EARLY BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THERE WAS TRANSIENT OVERSENSING. THE POCKET WAS REOPENED AND THE CONNECTION CONFIRMED. THE LEAD CONNECTOR PIN WAS INSPECTED AND REINSERTED IN THE RV P/S PORT AND TIGHTENED DOWN, WITH OVERSENSING STILL PRESENT. A NEW DEVICE WAS USED. WHEN THE SECOND DEVICE WAS CONNECTED TO THE LEAD SYSTEM, OVERSENSING WAS AGAIN PRESENT. THE SECOND DEVICE WAS LEFT IN PLACE AND THE PATIENT MONITORED FOR A FEW DAYS TO CHECK FOR OVERSENSING, WITH NO FURTHER OVERSENSING ISSUES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A QUESTION AS TO WHY THE DEVICE LASTED ONLY 23 MONTHS. THE DEVICE REMAINS IN USE. 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 CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MDT PUERTO RICO OPERATIONS CO, MED REL D284TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Hospitalization| R| O 4194 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD