BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2810715 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06045
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 DEVICE WAS RETURNED AND ANALYZED. CALCULATIONS BASED ON IMPLANT PARAMETERS INDICATE THAT THE DEVICE HAD MET ITS 99.9% EXPECTED LONGEVITY. ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI (ELECTIVE REPLACEMENT INDICATOR) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE. THIS DEVICE IS PART OF THE FIELD ACTION AND HAS TESTED CONSISTENT WITH THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PATIENT HAD THREE EMERGENCY ROOM (ER) VISITS AND THOUGHT THAT THEY WERE "GOING TO DIE." FOLLOW-UP CLARIFIED THAT THE PATIENT EXPERIENCED PACEMAKER SYNDROME WHEN THE DEVICE INDICATED NORMAL ELECTIVE REPLACEMENT (ERI). WHEN THE DEVICE BEGAN PACING IN A VENTRICULAR-ONLY MODE AT 65 BEATS PER MINUTE, THE PATIENT WAS SYMPTOMATIC. THE PATIENT FURTHER REPORTED THEIR SYMPTOMS FOR EACH ER VISIT WHICH INCLUDED: IT FELT LIKE THEIR HEART WAS "FLOPPING", UNABLE TO EAT, THEY WERE DIZZY, UNFOCUSED AND DEPRESSED, SHORT OF BREATH, SHAKING, FELT LIKE HAVING SOME SORT OF SPASMS, AND ALMOST PASSED OUT WHEN GETTING OUT OF BED. THE DEVICE WAS EXPLANTED 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
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 5054 IMPLANTABLE PACING LEAD| 5554 IMPLANTABLE PACING LEAD