BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 1990532 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00742
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    Z-1172-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    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): PRELIMINARY ANALYSIS NOTED THAT 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 INDICATED THAT THE BATTERY WAS NOT INTERNALLY SHORTED. UPON FURTHER ANALYSIS, EXAMINATION OF DEVICE DATA INDICATED THAT A HIGH CURRENT CONDITION EXISTED WHEN THE BATTERY WAS APPROXIMATELY 3.06 VOLTS. THE DEVICE WAS MONITORED AND EXAMINED IN VARIOUS MODES IN ATTEMPTS TO INDUCE A HIGH CURRENT CONDITION. A HIGH CURRENT CONDITION WAS NOT OBSERVED DURING EVALUATION OF THE DEVICE. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY VOLTAGE - BATTERY DEPLETION INDICATED/ERI TIME OF ERI IN SAVE TO DISK ON (B)(6)-2010 02:15:03 DEVICE ERI <=2.61 V. LAST BATTERY MEASUREMENT=2.58 VOLT ON (B)(6)-2010 09:44:07. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.62 TO 2.55 VOLTS BETWEEN (B)(6)-2010. ONE - PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(6)-2010 02:15:03. (B)(4) CHARGE TIME - LONG CHARGE TIME ERI (B)(4) 1 - PATIENT ALERT FOR CHARGE CIRCUIT TIMEOUT ON (B)(6)-2010 20:05:12. ONE - PATIENT ALERT FOR EXCESSIVE CHARGE TIME ON (B)(6)-2010 20:05:52. FURTHER ANALYSIS OF THE BATTERY DID NOT FIND A ROOT CAUSE OF THE RAPID VOLTAGE DEPLETION SEEN IN THE PERFORMANCE DATA VOLTAGE CURVE. BASED ON DESTRUCTIVE ANALYSIS, NO INTERNAL SHORT WAS PRESENT.

    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): PRELIMINARY ANALYSIS NOTED THAT 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 INDICATED THAT THE BATTERY WAS NOT INTERNALLY SHORTED. UPON FURTHER ANALYSIS, EXAMINATION OF DEVICE DATA INDICATED THAT A HIGH CURRENT CONDITION EXISTED WHEN THE BATTERY WAS APPROXIMATELY 3.06 VOLTS. THE DEVICE WAS MONITORED AND EXAMINED IN VARIOUS MODES IN ATTEMPTS TO INDUCE A HIGH CURRENT CONDITION. A HIGH CURRENT CONDITION WAS NOT OBSERVED DURING EVALUATION OF THE DEVICE. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY VOLTAGE - BATTERY DEPLETION INDICATED/ERI TIME OF ERI IN SAVE TO DISK ON (B)(6) 2010 02:15:03 DEVICE ERI <=2.61 V. LAST BATTERY MEASUREMENT=2.58 VOLT ON (B)(6) 2010 09:44:07. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.62 TO 2.55 VOLTS BETWEEN (B)(6) 2010 AND (B)(6) 2010. 1 - PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(6) 2010 02:15:03. (B)(4): CHARGE TIME - LONG CHARGE TIME ERI (B)(4): 1 - PATIENT ALERT FOR CHARGE CIRCUIT TIMEOUT ON (B)(6) 2010 20:05:12. 1 - PATIENT ALERT FOR EXCESSIVE CHARGE TIME ON (B)(6) 2010 20:05:52.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ELECTIVE REPLACEMENT INDICATOR WAS TRIGGERED DUE TO PREMATURE BATTERY DEPLETION. LONG DEVICE CHARGE TIME ALSO REPORTED. THE DEVICE WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ELECTIVE REPLACEMENT INDICATOR WAS TRIGGERED DUE TO PREMATURE BATTERY DEPLETION. LONG DEVICE CHARGE TIME ALSO REPORTED. THE DEVICE WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD