BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA DR

    MDR report key: 1991657 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00908
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT STATED THAT HER "HEART RATE IS UP AND SHE FEELS A FAINT THUMPING IN CHEST AREA SINCE NEW LEAD IMPLANTED." THE PATIENT SAID THE LEAD IS TOO LONG AND IT'S CURVED IN HER BODY AND CAUSES DISCOMFORT. ACCORDING TO AVAILABLE INFORMATION, NO LEADS HAVE BEEN IMPLANTED SINCE 2000. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT STATED THAT HER "HEART RATE IS UP AND SHE FEELS A FAINT THUMPING IN CHEST AREA SINCE NEW LEAD IMPLANTED." THE PATIENT SAID THE LEAD IS TOO LONG AND IT'S CURVED IN HER BODY AND CAUSES DISCOMFORT. ACCORDING TO AVAILABLE INFORMATION, NO LEADS HAVE BEEN IMPLANTED SINCE 2000. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT WAS THAT SHE FEELS SOME "PAIN" AND IS UNCOMFORTABLE "WHERE THE LEAD IS PLACED." INFORMATION OBTAINED THROUGH FOLLOW UP WITH THE PHYSICIAN OFFICE INDICATED THAT THE PHYSICIAN NOTED SOME HIGH ATRIAL RATES, WHICH WERE "SHORT-LIVED" AND THAT THE PATIENT HAS A HISTORY OF A-FIB. ALSO NOTED WERE MODE SWITCHES VIA CARELINK, BUT NO SVT/VT. THE LEAD AND DEVICE REMAIN 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 VERSA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. VEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other (B)(4) IMPLANTABLE PACING LEAD| 4568 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| 4568 IMPLANTABLE PACING LEAD