BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK SYSTEM

    MDR report key: 2131037 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00886
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 21, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/102
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. PLEASE NOTE THE INITIAL REPORT FOR THIS COMPLAINT WAS TIMELY SUBMITTED ON 08/10/2011; HOWEVER, THE INCORRECT SUSPECT MEDICAL DEVICE WAS REFLECTED. THEREFORE, CORRECTION TO THE DEVICE INVOLVED IS BEING MADE TO ACCURATELY REFLECT MODEL ADSR01 ACCORDINGLY. CONSEQUENTLY, THE INITIAL REPORT SUBMITTED ON 10AUG2011 MFG REPORT NUMBER 2182208000201100886 WITH INCORRECT MODEL CARELINK CONGO IS BEING REDACTED AND THEREFORE SHOULD BE DISREGARDED. SUPPLEMENTAL (INITIAL) REPORT SUBMITTED 10/10/2011 FOR THE CORRECT DEVICE ADSR01 ASSOCIATED WITH THIS REPORTABLE COMPLAINT SHOULD BE CONSIDERED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER WAS QUESTIONING THE NON-MAGNET EGM OF A NEWLY IMPLANTED PACEMAKER. THE EGM WAS SHOWING "DASHED, VERTICAL LINES." TECHNICAL SERVICES EXPLAINED THAT THIS COULD INDICATE A LOSS OF TELEMETRY. THE PATIENT HAD SYMPTOMS. FURTHER INVESTIGATION DID NOT YIELD ANY ADDITIONAL INFORMATION. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER WAS QUESTIONING THE NON-MAGNET EGM OF A NEWLY IMPLANTED PACEMAKER. THE EGM WAS SHOWING "DASHED, VERTICAL LINES." THE CARELINK MONITOR REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK SYSTEM SOFTWARE NVZ MEDTRONIC, INC. CARELINK CONGO ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| D154ATG IMPLANTABLE PACEMAKER/CARDIO/DEFIB