BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 1792360 · Received August 11, 2010

    Report

    Report Number
    6000144-2010-03228
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    May 6, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION: CHANGED OPER CODE FOR DEVICE 1 FROM HEALTH PROFESSIONAL TO LAY USER/PATIENT. 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. PRIMARY ANALYSIS FINDING: OVERSENSING WAS NOTED. THE EGM SIGNAL AND THE RANDOMNESS OF THE OVERSENSING IS NOT CONSISTENT WITH POWER LINE NOISE. POWER LINES CARRY 60 CYCLES PER SECOND ALTERNATING CURRENT (AC) WHICH PRODUCES A MUCH LESS ERRATIC WAVEFORM AND TYPICALLY PRODUCES CONSISTENT INTERVALS BETWEEN THE SENSED (OVERSENSED) MARKERS. GIVEN THAT THE LEADS SEEM TO BE INTACT, AND THE NOISE IS PRODUCING BOTH V & A OVERSENSING, OTHER SOURCES OF INTERFERENCE IN THE PT'S ENVIRONMENT ARE SUSPECT AND SHOULD BE ASSESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR HAD RECORDED HIGH RATE EVENTS. THE EVENTS APPEARED TO BE DUE TO EXTERNAL SOURCES (HIGH VOLTAGE POWER LINES AND A WELDER). THE PATIENT IS NO PACEMAKER DEPENDENT AND THERE WERE NO PATIENT COMPLAINTS NOR COMPLICATIONS REPORTED DUE TO THIS ISSUE. THE DEVICE REMAINS IMPLANTED AND ACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 3830 IMPLANTABLE PACING LEAD