BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 2131095 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01133
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. 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. BATTERY VOLTAGE - PRE/APPROACHING ELECTIVE REPLACEMENT INDICATOR. WEEKLY TREND IN SAVE TO DISK DATA SHOWS MIN BAT= 2.62 VOLTS IN WEEK OF (B)(6) 2010, IS BEFORE RRT<= 2.61 VOLT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY FOR (B)(4): ANALYSIS REVEALED THAT THE DEVICE DID NOT MEET EXPECTED LONGEVITY, THE CAUSE IS UNKNOWN. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY VOLTAGE - PRE/APPROACHING ELECTIVE REPLACEMENT INDICATOR. WEEKLY TREND IN SAVE TO DISK DATA SHOWS MIN BAT= 2.62 VOLTS IN WEEK OF (B)(6) 2010, IS BEFORE RRT<= 2.61 VOLT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D154ATG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACING LEAD