BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 1992029 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00978
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    March 5, 2010
    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
    NY, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND.

    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

    THE PATIENT REPORTED THAT THE DEVICE HAS BEEN "PULSATING" IN ABDOMEN, BECOMING WORSE IN THE LAST SEVERAL WEEKS. THE PATIENT ALSO REPORTED THAT THE DEVICE HAS BEEN REPROGRAMMED 6 TIMES, AND THAT THE NURSE SAID THAT IT CAN NOT BE PROGRAMMED "ANY LOWER". THE PATIENT FURTHER REPORTED THAT THIS HAS CAUSED A 17 POUND FLUID GAIN IN JUST A FEW WEEKS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE EPICARDIAL LEAD CONTINUES TO CAUSE MUSCLE STIMULATION ALONG WITH LOSS OF CAPTURE AND ASYSTOLIC EPISODES WHEN HIGH OUTPUTS ARE SET ON THE DEVICE. THE LEAD AND DEVICE HAVE BEEN REPROGRAMMED AND REMAINS IN USE. FOLLOW UP INFORMATION REVEALED THAT THE PATIENT IS SCHEDULED FOR A REPLACEMENT IN THE COMING WEEKS. FURTHER INFORMATION REVEALED THAT THE PATIENT PASSED OUT. THE DEVICE WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE DEVICE HAS BEEN "PULSATING" IN ABDOMEN, BECOMING WORSE IN THE LAST SEVERAL WEEKS. THE PATIENT ALSO REPORTED THAT THE DEVICE HAS BEEN REPROGRAMMED 6 TIMES, AND THAT THE NURSE SAID THAT IT CAN NOT BE PROGRAMMED "ANY LOWER". THE PATIENT FURTHER REPORTED THAT THIS HAS CAUSED A 17 POUND FLUID GAIN IN JUST A FEW WEEKS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE DEVICE HAS BEEN "PULSATING" IN ABDOMEN, BECOMING WORSE IN THE LAST SEVERAL WEEKS. THE PATIENT ALSO REPORTED THAT THE DEVICE HAS BEEN REPROGRAMMED 6 TIMES, AND THAT THE NURSE SAID THAT IT CAN NOT BE PROGRAMMED "ANY LOWER". THE PATIENT FURTHER REPORTED THAT THIS HAS CAUSED A (B)(6) FLUID GAIN IN JUST A FEW WEEKS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE EPICARDIAL LEAD CONTINUES TO CAUSE MUSCLE STIMULATION ALONG WITH LOSS OF CAPTURE AND ASYSTOLIC EPISODES WHEN HIGH OUTPUTS ARE SET ON THE DEVICE. THE LEAD AND DEVICE HAVE BEEN REPROGRAMMED AND REMAINS IN USE. FOLLOW UP INFORMATION REVEALED THAT THE PATIENT IS SCHEDULED FOR A REPLACEMENT IN THE COMING WEEKS.

    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 50 YR Hospitalization| L| R 5071 IMPLANTABLE PACING LEAD| 5071 IMPLANTABLE PACING LEAD| 4968 IMPLANTABLE PACING LEAD| 5071 IMPLANTABLE PACING LEAD