BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III PROTECT

    MDR report key: 2122543 · Received June 13, 2011

    Report

    Report Number
    6000094-2011-00700
    Event Type
    Injury
    Date Received
    June 13, 2011
    Report Date
    July 12, 2019
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 1

    CORRECTED: PREVIOUSLY SUBMITTED FOLLOW-UP REPORT #002 HAD THE COUNTER INCREMENTED INCORRECTLY (DUE TO A CORRECTION TO THE IDENTITY OF THE DEVICE, SEE DUPLICATE EVENT 2182208-2011-00577), SO THIS REPORT IS BEING SUBMITTED AS A PLACEHOLDER WITH THE SEQUENCE #001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP VISIT, THE DEVICE WAS FOUND TO BE AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT COMPLAINED ABOUT PREMATURE BATTERY DEPLETION. IT WAS FURTHER REPORTED VIA FOLLOW UP THAT 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 III PROTECT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC EUROPE SARL 7285 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R