BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC MAXIMO

    MDR report key: 1882266 · Received October 26, 2010

    Report

    Report Number
    6000144-2010-05592
    Event Type
    Death
    Date Received
    October 26, 2010
    Date of Event
    May 19, 2009
    Report Date
    October 15, 2024
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. EVALUATION SUMMARY: (B)(4) FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDINGS: NO ANOMALIES FOUND. BLOOD IN/ON HELIX/LOBE MECHANISM. (B)(4) - BATTERY DEPLETION-NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS REMOVED AND REPLACED DUE TO INCREASED ATRIAL THRESHOLDS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVELED THE PATIENT HAD DIED. FOLLOW UP WITH THE PHYSICIAN REPORTED HE LAST SAW PATIENT IN CLINIC (B)(6)2009 AND THAT PATIENT WAS "GETTING KIND OF TIRED." PATIENT PRESENTED TO ER (B)(6)2009 "IN FLORID RESPIRATORY FAILURE AND SHOCK" WITH PHYSICIAN NOTING "THE PATIENT'S OVERALL PROGNOSIS IS POOR." THE PATIENT WAS MADE A DO NOT RESUSCITATE AND DIED (B)(6)2009 WITH CAUSE OF DEATH REPORTED AS RESPIRATORY RELATED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC MAXIMO IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7304 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female Required Intervention| D 4193 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD