BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1861566 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04794
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 7, 2010
    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
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    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 DEVICE WAS RETURNED AND ANALYZED. PRIMARY RESULTS REVEALED THAT IT DID NOT MEET EXPECTED LONGEVITY, CAUSE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM AFTER HEARING THE ALERT GO OFF. THREE MONTHS PRIOR THE DEVICE HAD A POWER ON RESET OCCUR. A SAVE TO DISC WAS NOT ABLE TO BE COLLECTED AT THIS POINT DUE TO A MEMORY STICK NOT WORKING. THE DIAGNOSTIC DATA WAS CLEARED AND NEW DATA IS NOW BEING COLLECTED. THE LEAD INTEGRITY ALERT ALGORITHM WAS RE-LOADED INTO THE DEVICE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM AFTER HEARING THE ALERT GO OFF. THREE MONTHS PRIOR, THE DEVICE HAD A POWER ON RESET OCCUR. A SAVE TO DISC WAS NOT ABLE TO BE COLLECTED AT THIS POINT DUE TO A MEMORY STICK NOT WORKING. THE DIAGNOSTIC DATA WAS CLEARED AND NEW DATA IS NOW BEING COLLECTED. THE LEAD INTEGRITY ALERT ALGORITHM WAS RE-LOADED INTO THE DEVICE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 83 YR Other| R 6948 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 5554 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5554 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 6948 IMPLANTABLE TACHY LEAD