BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 3992925 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14728
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT ENDURED "PAIN AND SUFFERING" SINCE THE DEVICE WENT TO "BATTERY SAVING MODE" AND THE PATIENT IS PACEMAKER DEPENDENT. ALSO, PATIENT WAS ON VACATION WHEN THE DEVICE MODE SWITCHED, WHICH CAUSED THE PATIENT TO HAVE NO ENERGY AND THE VACATION WAS "RUINED."

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THE DEVICE CHECKED AND UNDERSTOOD THE DEVICE LONGEVITY WAS ONE TO EIGHT MONTHS BEFORE REPLACEMENT WAS NEEDED. THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR TWO WEEKS AFTER THE DEVICE CHECK. THE PATIENT FELT "HORRIBLE" WHEN THE DEVICE SWITCHED TO BATTERY SAVING MODE. THE DEVICE WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467258 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R 5076-45 LEAD, 5068-58 LEAD