BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III PROTECT

    MDR report key: 2951769 · Received February 9, 2013

    Report

    Report Number
    6000094-2013-00001
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 5, 2012
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 80% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO PREMATURE BATTERY DEPLETION. THEREFORE THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57427 INSYNC III PROTECT NIK MEDTRONIC S.A. (SMO) 7285

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R 4574 IMPLANTABLE PACING LEAD