BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 1791358 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03104
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE VENTRICULAR SENSING INTEGRITY COUNTER IS 2785 AND ALL COUNTS OCCURRED SINCE (B)(6) 2009. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE A FEW NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES WHICH LOOKED LIKE NOISE ON BOTH CHANNELS. THE PHYSICIAN THOUGHT THAT THIS WAS DUE TO EXTERNAL ELECTROMAGNETIC NOISE CAUSING INTERFERENCE SIMULTANEOUSLY ON BOTH LEADS. LEAD IMPEDANCES WERE STEADY AND THE DOCTOR DID NOT THINK THIS WAS A LEAD ISSUE. THERE WAS ALSO A WARNING FOR HIGH VENTRICULAR SHORT INTERVAL COUNT, WHICH INDICATE OVERSENSING. 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
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other 5076 (X2) IMPLANTABLE PACING LEADS