BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 3992881 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14735
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. CONCOMITANT PRODUCT: 1388TC LEAD, IMPLANTED: (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON GETTING UP AT 4 AM THE PATIENT HAD A SYNCOPAL EPISODE AND FELL AND HIT THEIR CHEEK, WHICH CAUSED SOME BRUISING. THE PATIENT WAS NOTED TO HAVE BRADYCARDIA, AND ALSO REPORTED HAVING FLU-LIKE SYMPTOMS FOR THE PAST FEW DAYS. AFTER BEING TRANSPORTED TO THE HOSPITAL THE DEVICE WAS INTERROGATED AND THRESHOLDS AND ALL OTHER FUNCTIONS WERE NORMAL. IT WAS NOTED THAT SLEEP FUNCTION WAS ON DURING THAT TIMEFRAME. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS SUBSEQUENTLY SEEN BY THEIR CARDIOLOGIST. THE DEVICE WAS FOUND TO BE FUNCTIONING FINE AND NO PROGRAMMING CHANGES WERE MADE. THE PATIENT HAS A HISTORY OF VASOVAGAL SYNCOPE, AND THE PHYSICIAN DID NOT BELIEVE THAT THE DEVICE BEING IN SLEEP FUNCTION MODE PLAYED ANY ROLE IN THE EPISODE. THE DEVICE IS STILL 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
    471848 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Hospitalization| L 4463 LEAD