BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 1013416 · Received March 10, 2008

    Report

    Report Number
    6000144-2008-00050
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    December 7, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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: ACTUAL LONGEVITY IS < 80% OF 99.9% LONGEVITY LIMIT. ANALYSIS CONFIRMED THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. 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. IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE ICD MALFUNCTIONED AND THAT THE ICD WAS PROGRAMMED OFF. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION REPORTS THE DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION. AACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED MECHANICAL TESTS PERFORMED VISUAL EXAMINATION DEVICE WAS OUT OF SPECIFICATION IN A MANNER THAT RELATES TO EVENT PERFORMANCE PREMATURE ERI (ELECTIVE REPLACEMENT INDICATOR).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE ICD MALFUNCTIONED AND THAT THE ICD WAS PROGRAMMED OFF. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION REPORTS THE DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC MAXIMO IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 4193 IMPLANTABLE PACING LEAD| 6944 IMPLANTABLE TACHY LEAD| 5568 IMPLANTABLE PACING LEAD