BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II DR

    MDR report key: 3160429 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10081
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0113-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS BASED SOLELY ON DEVICE 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.PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE ACTUAL LONGEVITY WAS LESS THAN 80% OF THE 99.9% LONGEVITY LIMIT. 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. CONITNUATION: (B)(4) IMPLANTABLE PACING LEAD - 2010-(B)(6).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER WITH NO REASON FOR REPLACEMENT. THE DEVICE WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW-UP WAS CONDUCTED AND FROM THE INFORMATION THAT WAS OBTAINED IT WAS FURTHER REPORTED THAT THE DEVICE ERI (ELECTIVE REPLACEMENT INDICATOR) WAS REACHED EARLY DUE TO CHRONIC HIGH RIGHT VENTRICULAR (RV) LEAD THRESHOLDS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259277 MAXIMO II DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D284DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R (B)(4) IMPLANTABLE TACHY LEAD