BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC SENTRY

    MDR report key: 1894604 · Received November 10, 2010

    Report

    Report Number
    6000144-2010-05603
    Event Type
    Death
    Date Received
    November 10, 2010
    Date of Event
    July 9, 2008
    Report Date
    October 16, 2024
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) BATTERY DEPLETION-NORMAL. (B)(4) OUTER INSULATION SEPARATION, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED). PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC CUT AND DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. CORRECTION TO DEVICE CONCLUSION SN (B)(4). (B)(4) BATTERY - BATTERY DEPLETION-NORMAL.

    Description of Event or Problem · 1

    LEAD WAS RETURNED TO MANUFACTURER FOLLOWING PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THERE IS NO ALLEGATION FROM HEALTH CARE PROFESSIONAL THAT DEATH WAS DEVICE RELATED. FOLLOW UP REVEALED NORMAL DEVICE FUNCTION NOTED APPROXIMATELY 2 WEEKS PRIOR TO PATIENT DEATH. CAUSE OF DEATH REPORTED AS PULMONARY HYPERTENSION AND RIGHT SIDED HEART FAILURE. FOLLOW UP REVEALED PATIENT HAD BEEN ADMITTED TO HOSPITAL (B)(6) 2008 FOR CEREBELLAR HEMORRHAGE, ANEMIA, AND PULMONARY HYPERTENSION DURING WHICH TIME, WAS RESTARTED ON ANTICOAGULATION MEDICATION DUE TO CLOTTING CONCERN. PATIENT DISCHARGED STABLE WITH A CODE STATUS OF DO NOT RESUSCITATE ON APPROXIMATELY (B)(6) 2008. SUMMARY REPORT NOTED AT DEVICE CHECK (B)(6) 2007, THERE MAY HAVE BEEN SOME FFRW OVERSENSING OBSERVED, BUT AT APPOINTMENT, PATIENT WAS IN ATRIAL TACHYCARDIA VERSUS ATYPICAL FLUTTER. NO REPROGRAMMING DONE. ON (B)(6) 2008, DEVICE CHECK HAD AGAIN NOTED OVERSENSING.

    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 60 YR Female Life Threatening| H| R| D