BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1920894 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05664
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 25, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY FOR (B)(4): THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER AFTER FEELING FATIGUED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT PACING AND WAS REPROGRAMMED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS INVOLVED IN AN AUTOMOBILE ACCIDENT ABOUT 1 TO 1.5 MONTHS EARLIER. THE PATIENT STATED HE DID "FEEL FUNNY" AT THE TIME OF THE ACCIDENT, BUT WAS UNSURE IF IT WAS CORRELATED TO THE DEVICE OR THE RESULT OF THE ACCIDENT. NO FURTHER 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 56 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| (B)(4) HEART VALVE| 4194 IMPLANTABLE PACING LEAD| (B)(4) HEART VALVE| 6940 IMPLANTABLE PACING LEAD