BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2791256 · Received October 15, 2012

    Report

    Report Number
    2647346-2012-01707
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    June 6, 2012
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PALPITATIONS, SHORTNESS OF BREATH, CONSTANT FATIGUE, CHEST HEAVINESS, AND A FEELING OF THEIR HEART RACING AT REST SINCE IMPLANT. IT WAS NOTED THAT THE PATIENT RECEIVED RATE RESPONSIVE ATRIOVENTRICULAR (AV) PACING NEAR UNDERLYING SINUS RHYTHM WHILE RESTING OR ASLEEP. A CHEST X-RAY AND AN ECHOCARDIOGRAM WITH AV OPTIMIZATION WERE PERFORMED. THE RATE RESPONSE SETTING WAS ADJUSTED AND THE AV DELAY WAS REPROGRAMMED; HOWEVER, THE SYMPTOMS CONTINUED TO PERSIST. RATE RESPONSE WAS THEN TURNED OFF AND THE PATIENT STILL EXPERIENCED SYMPTOMS. PER THE PHYSICIAN, THE PATIENT EXPERIENCED ALL OF THE SYMPTOMS PRIOR TO DEVICE IMPLANT AND IT COULD NOT BE DETERMINED IF THE SYMPTOMS WERE RELATED TO A DEVICE ISSUE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN 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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention 5076-2 IMPLANTABLE PACING LEAD| 5076-1 IMPLANTABLE PACING LEAD