BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA DR

    MDR report key: 1796602 · Received August 12, 2010

    Report

    Report Number
    6000144-2010-03820
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    June 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    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 IS REPORTED THAT PATIENT HAD CALLED TECH SERVICES AND STATED THAT HE IS EXPERIENCING PAIN AT THE PACEMAKER IMPLANT SITE. TECH SERVICES HAD RECOMMENDED TO WORK WITH HIS DOCTOR. DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT HAD CALLED TECH SERVICES AND STATED THAT HE IS EXPERIENCING PAIN AT THE PACEMAKER IMPLANT SITE. TECH SERVICES HAD RECOMMENDED TO WORK WITH HIS DOCTOR. DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED PATIENT IS FEELING 'SHORT OF BREATH' AND 'DIZZINESS' WHEN HE WALKS. IT ALSO WAS REPORTED THAT PATIENT WAS FEELING THIS WAY FOR A 'COUPLE OF WEEKS' AND THE LAST DEVICE CHECK WAS FEW WEEKS BEFORE THE SYMPTOMS BEGAN AT WHICH TIME HE WAS TOLD EVERYTHING WAS 'OKAY' WITH THE PACEMAKER. THE DEVICE REMAINS IN USE. NO FURTHER 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 ASKU NVZ MEDTRONIC MED REL, INC. VEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other 5568 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD