BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL DX

    MDR report key: 1791821 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03055
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    December 2, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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) ANALYSIS CONFIRMED THE DEVICE HAD NON-FUNCTIONAL SENSING, DUE TO CONTINUOUS OVERSENSING/NOISE. THE CAUSE WAS A LEAKAGE PATH ON THE HYBRID PADS ATTACHED TO THE INTEGRATED CIRCUIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS MULTIPLE ASYSTOLE AND FVT EPISODES. THERE WAS NO IMPROVEMENT WITH REPROGRAMMING. THE PATIENT UNDERWENT A PROCEDURE FOR DEVICE EVALUATION, IN WHICH THE DEVICE WAS FOUND TO HAVE BEEN IMPLANTED "UPSIDE DOWN" FOR SIX WEEKS. IT WAS REIMPLANTED IN THE CORRECT POSITION, BUT PROPER SENSING AFTER REIMPLANTATION COULD NOT BE OBTAINED, AND NOISE WAS STILL OBSERVED. A NEW DEVICE WAS IMPLANTED IN THE SAME POCKET, WITH PROPER SENSING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVEAL DX IMPLANTABLE LOOP RECORDER DSI MEDTRONIC MED REL, INC. 9528 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention