BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 2051953 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01559
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. TIME OF ERI (ELECTIVE REPLACEMENT INDICATOR) IN SAVE TO DISK ON (B)(4)-2011 03:00:02, DEVICE ERI <=2.62 V. 1 - PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(4)-2011 03:00:02. WEEKLY LOG BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.64 TO 2.62 VOLTS BETWEEN (B)(4)-2010 AND (B)(4)-2011.

    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): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TIME OF ERI (ELECTIVE REPLACEMENT INDICATOR) IN SAVE TO DISK ON (B)(4)-2011, DEVICE ERI <=2.62 V. 1 - PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(4)-2011. WEEKLY LOG BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.64 TO 2.62 VOLTS BETWEEN (B)(4)-2010 AND (B)(4)-2011.

    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): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TIME OF ERI (ELECTIVE REPLACEMENT INDICATOR) IN SAVE TO DISK ON (B)(6) 2011, DEVICE ERI <=2.62 V. 1 - PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(6) 2011. WEEKLY LOG BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2010 AND (B)(6) 2011. ANALYSIS REVEALED THAT THE DEVICE DID NOT MEET EXPECTED LONGEVITY, THE CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT LAST AS LONG AS EXPECTED. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT LAST AS LONG AS EXPECTED. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ADDITIONALLY REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR. THE DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT LAST AS LONG AS EXPECTED. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ADDITIONALLY REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7299 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD