BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 1923033 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-06033
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    May 19, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. ANALYSIS INDICATES THAT BATTERY DEPLETION/ELECTIVE REPLACEMENT INDICATED A MEEASUREMENT SYSTEM LOCK-UP ERROR OCCURED. THE ELECTIVE REPLACEMENT INDICATOR WAS TRIPPED ON (B)(4)2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED RECOMMENDED REPLACED AFTER ONE YEAR. IT WAS ALSO REPORTED THE PATIENT IS SYMPTOMATIC IN THE MODE OF VVI 65 MODE AND THE PHYSICIAN WOULD LIKE TO REPROGRAM THE DEVICE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other 5076 (X2) IMPLANTABLE PACING LEAD