BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 4499754 · Received February 10, 2015

    Report

    Report Number
    3004209178-2015-02381
    Event Type
    Injury
    Date Received
    February 10, 2015
    Date of Event
    November 5, 2014
    Report Date
    November 5, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINE THAT THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT MEDICAL PRODUCTS: 1346T, COMPETITOR LEAD, IMPLANTED: (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS HAVING ARRHYTHMIA PROBLEMS. THE PATIENT WENT TO THE ER (EMERGENCY ROOM) AS THEY WERE FEELING POORLY AND DIZZY. THE DEVICE WAS REPROGRAMMED TO ALLOW THE HEART TO PACE ON ITS OWN MORE. THE PATIENT¿S EF (EJECTION FRACTION) CAME UP AND THE PATIENT WAS FEELING BETTER. IT WAS NOTED THAT HE PHYSICIAN WANTS TO USE MEDICATIONS INSTEAD OF THE PACEMAKER TO CONTROL THE ARRHYTHMIAS; HOWEVER, THE PATIENT IS NOT SURE THEY WANT TO TAKE THE MEDS. ADDITIONALLY, IT WAS REPORTED THAT AT THE PATIENT¿S LAST VISIT IT WAS OBSERVED THAT THE PACEMAKER WAS PACING MOST OF THE TIME AND WHEN THE PATIENT ASKED THE PHYSICIAN ABOUT THE INCREASED PACING THE PHYSICIAN DID NOT ANSWER WHY. THE PATIENT IS NOT HAPPY WITH THE PHYSICIAN AND REQUEST LIST OF OTHER DOCTORS IN THE AREA. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94045 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention 1388T COMPETITOR LEAD