BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 2533275 · Received April 12, 2012

    Report

    Report Number
    6000094-2012-00898
    Event Type
    Injury
    Date Received
    April 12, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. 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 - BATTERY DEPLETION INDICATED/ERI: TIME OF ERI IN SAVE TO DISK ON (B)(6) 2012, DEVICE ERI<=2.62 VOLT. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN B(V)=2.64 TO 2.62 VOLTS MINIMUM BETWEEN (B)(6) 2012. 2 - PATIENT ALERTS FOR LOW BV ON (B)(6) 2012 03:00:02 AND (B)(6) 2012 03:00:03.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATORS (ERI) AFTER THREE AND A HALF YEARS. 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 INSYNC MAXIMO IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7304

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R