BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA DR

    MDR report key: 1822008 · Received September 1, 2010

    Report

    Report Number
    2647346-2010-00511
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    May 3, 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
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. FOLLOW UP WITH CLINIC REPORTED THE PATIENT WAS NEVER SEEN THERE AND "IT LOOKED LIKE THIS PATIENT NEVER LEFT THE HOSPITAL AFTER IMPLANT." FIVE DAYS AFTER IMPLANT, PATIENT HAD ECHO THAT REVEALED A "TRIVIAL PERICARDIAL EFFUSION." THIRTEEN DAYS AFTER THIS, NOTE THAT THE WOUND CHECK AT THE HOSPITAL SHOWED HEALING FINE. IT WAS ALSO REPORTED THERE WAS ATRIAL CAPTURE AND THERE WAS NO DEVICE MALFUNCTION. THE PATIENT HAD MULTIPLE CO-MORBIDITIES (INCLUDING A MAJOR BOWEL OBSTRUCTION AFTER CARDIAC SURGERY) AND HAD RECEIVED PACEMAKER AFTER HAVING HAD CARDIAC SURGERY. PATIENT HAD NOT BEEN PACEMAKER DEPENDENT AND THE PACEMAKER WAS FUNCTIONING NORMALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS DIFFICULTY ASSESSING ATRIAL CAPTURE. PACING AT HIGH OUTPUTS WAS TRIED, BUT THERE WAS STILL NO CONDUCTION. BOTH BIPOLAR AND UNIPOLAR TESTING WAS TRIED, BUT THERE WAS STILL TROUBLE ASSESSING CAPTURE. P-WAVES AT IMPLANT, THREE WEEKS PRIOR, WERE ONLY 0.25 MV AND CAPTURE THRESHOLD WAS 1.5V. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE STATED THAT UPON FURTHER REVIEW IT WAS DETERMINED THE ATRIAL LEAD WAS CAPTURING. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED (B)(6) 2010. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS DIFFICULTY ASSESSING ATRIAL CAPTURE. PACING AT HIGH OUTPUTS WAS TRIED, BUT THERE WAS STILL NO CONDUCTION. BOTH BIPOLAR AND UNIPOLAR TESTING WAS TRIED, BUT THERE WAS STILL TROUBLE ASSESSING CAPTURE. P-WAVES AT IMPLANT, THREE WEEKS PRIOR TO THE REPORTED EVENT, WERE ONLY 0.25 MV AND CAPTURE THRESHOLD WAS 1.5V. IT WAS ALSO REPORTED THE PATIENT HAS HAD MULTIPLE MEDICAL ISSUES BEFORE AND SINCE IMPLANT. AN X-RAY OF THE LEAD POSITION WAS SUGGESTED. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE STATED THAT UPON FURTHER REVIEW IT WAS DETERMINED THE LEAD WAS CAPTURING. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED (B)(6)2010. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA DR ASKU NVZ MEDTRONIC MED REL, INC. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| L| R