BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II DR

    MDR report key: 2051171 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01508
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    January 25, 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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): ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. IT WAS REPORTED BY THE ANALYST THAT THE BATTERY IS DEPLETED DUE TO THE EXCESSIVE CUMULATIVE CHARGE TIME OF OVER 1600 SECONDS, RESULTING IN MULTIPLE POWER-ON RESETS. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND THERE WAS FOUND TO HAVE BEEN ISSUES WITH THE POWER-ON-RESET PARAMETERS. THERE WAS A POWER-ON-RESET FOR THE DVDD SUPPLY 1354 SELF SUPPLY ON (B)(4) 2011. THERE WAS A CHARGE TIME CHARGE CIRCUIT PROBLEM WITH THE TACHY PORTION. PATIENT ALERTS OCCURRED ON (B)(4) 2011 FOR A DEVICE CIRCUIT ERROR AND A CHARGE CIRCUIT TIMEOUT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION OF THE DEVICE, AN ALERT TONE WAS HEARD. TELEMETRY WAS LOST AND IT WAS DETERMINED THAT THE DEVICE HAD RESET AT THE TIME OF INTERROGATION. IT WAS ATTEMPTED TO CHARGE THE DEVICE BUT CHARGE CIRCUIT TIME OUT OCCURRED. THE DEVICE REPLACEMENT WAS SCHEDULED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION OF THE DEVICE, AN ALERT TONE WAS HEARD. TELEMETRY WAS LOST AND IT WAS DETERMINED THAT THE DEVICE HAD RESET AT THE TIME OF INTERROGATION. IT WAS ATTEMPTED TO CHARGE THE DEVICE BUT CHARGE CIRCUIT TIME OUT OCCURRED. IT WAS FURTHER REPORTED THAT THE DEVICE HAS BEEN REMOVED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. IT WAS ALSO REPORTED THAT THE DEVICE HAD GONE TO ELECTIVE-REPLACEMENT-INDICATOR STATUS AND COULD NOT BE INTERROGATED. 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D284DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD