BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 2528116 · Received April 11, 2012

    Report

    Report Number
    6000144-2012-01894
    Event Type
    Injury
    Date Received
    April 11, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE: 2 - PATIENT ALERTS FOR RV.PACE LEAD Z ON (B)(6) 2012 03:00:03 AND (B)(6) 2012 03:00:03. DAILY PACE LEAD IMPEDANCE LOG DATA SHOWS AN ABRUPT INCREASE FOR RV PACE= 808 TO 2304 OHMS PEAK BETWEEN (B)(6) 2012. BATTERY VOLTAGE - BATTERY DEPLETION INDICATED/ERI: TIME OF ERI IN SAVE TO DISK ON (B)(6) 2009 DEVICE ERI<=2.62 VOLT, AND DEVICE EOL REACHED 3 MONTHS AFTER ERI. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN B(V)=2.61 TO 2.58 VOLTS MINIMUM BETWEEN (B)(6) 2010 AND (B)(6) 2012. 1 - PATIENT ALERT FOR LOW BV ON (B)(6) 2009 03:00:02 AND (B)(6) 2012 03:00:03. BATTERY VOLTAGE - LONG CHARGE TIME, NOT ERI (TACHY): 1- PATIENT ALERT FOR LONG CHARGE TIME =16.43 SEC ON (B)(6) 2012 23:20:04.

    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). PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE: 2 - PATIENT ALERTS FOR RV.PACE LEAD Z ON (B)(6) 2012 03:00:03 AND (B)(6) 2012 03:00:03. DAILY PACE LEAD IMPEDANCE LOG DATA SHOWS AN ABRUPT INCREASE FOR RV PACE= 808 TO 2304 OHMS PEAK BETWEEN (B)(6) 2012 AND (B)(6) 2012. BATTERY VOLTAGE - BATTERY DEPLETION INDICATED/ERI: TIME OF ERI IN SAVE TO DISK ON (B)(6) 2009 DEVICE ERI<=2.62 VOLT, AND DEVICE EOL REACHED 3 MONTHS AFTER ERI. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN B(V)=2.61 TO 2.58 VOLTS MINIMUM BETWEEN (B)(6) 2010 AND (B)(6) 2012. 1 - PATIENT ALERT FOR LOW BV ON (B)(6) 2009 03:00:02 AND (B)(6) 2012 03:00:03. BATTERY VOLTAGE - LONG CHARGE TIME, NOT ERI (TACHY): 1- PATIENT ALERT FOR LONG CHARGE TIME =16.43 SEC ON (B)(6) 2012 23:20:04. THE DEVICE LOST TELEMETRY AND FUNCTION DUE TO BATTERY DEPLETION. THE CAUSE OF THE DEPLETION CANNOT BE DETERMINED. THE DEVICE WAS FULLY FUNCTIONAL AND OPERATED UNDER NORMAL CURRENT DRAIN WHEN POWERED WITH AN EXTERNAL SUPPLY. THE RESIDUAL VOLTAGE AND IMPEDANCE INDICATES THAT THE BATTERY WAS NOT INTERNALLY SHORTED. SINCE NO SAVE TO DISK DATA COULD BE RETRIEVED FROM THE DEVICE AND NO OTHER DATA WAS PROVIDED FROM THE FIELD THERE IS NO WAY TO CONFIRM THIS RESULT. THE BATTERY DEPLETION WAS FOUND TO BE NORMAL AND MET EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE SPIKES. THE LEAD WAS EXAMINED DURING A DEVICE REPLACEMENT PROCEDURE DUE TO ELECTIVE REPLACEMENT INDICATORS (ERI), AND WAS FOUND TO EXHIBITED CONSISTENT, ACCEPTABLE IMPEDANCES MEASUREMENTS THROUGH BOTH THE ANALYZER AND THE NEW DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEAD 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 INSYNC MAXIMO IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7303

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD| 6948 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 5554 IMPLANTABLE PACING LEAD| 5554 IMPLANTABLE PACING LEAD| 6948 IMPLANTABLE TACHY LEAD