BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA SR

    MDR report key: 2071216 · Received April 27, 2011

    Report

    Report Number
    2647346-2011-00616
    Event Type
    Death
    Date Received
    April 27, 2011
    Date of Event
    April 14, 2011
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    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. LATER REPORTED THE PATIENT HAD DIED SIX DAYS AFTER THE IMPLANT ATTEMPT. "PHYSICIANS DO NOT SUSPECT THE ATTEMPTED PLACEMENT OF THE LEAD." EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED DAMAGE AT IMPLANT.

    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. LATER REPORTED THE PATIENT HAD DIED SIX DAYS AFTER THE IMPLANT ATTEMPT. "PHYSICIANS DO NOT SUSPECT THE ATTEMPTED PLACEMENT OF THE LEAD." ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A DEVICE AND VENTRICULAR LEAD IMPLANT, HOWEVER THE ATRIAL LEAD WAS NOT ABLE TO BE IMPLANTED AS THE PATIENT COMPLAINED OF CHEST PAINS. FLUOROSCOPY SHOWED POSSIBLE FLUID IN THE PERICARDIAL SAC AND PERICARDIOCENTESIS WAS ATTEMPTED. THE PATIENT WAS TAKED TO SURGERY AT THAT TIME. NEXT DAY, MANUFACTURER'S REPRESENTATIVE CHECKED DEVICE AND NOTED VENTRICULAR LEAD DID NOT CAPTURE AND APPEARED TO HAVE DISLODGED DUE TO THE OPEN HEART SURGERY. PATIENT WAS NOT PACER DEPENDENT AND DIED FOUR DAYS AFTER IMPLANT. PHYSICIAN DOES NOT SUSPECT LEADS OR DEVICE IN PATIENT'S DEATH. PATIENT IS REPORTED TO HAVE HAD MULTIPLE CONCOMMITANT MEDICAL PROBLEMS. CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH CLINIC REPORTED THAT PER HOSPITAL RECORDS, THE PATIENT HAD CODED WITH SECOND DEGREE HEART BLOCK AND NEAR SYNCOPE. NOTED TRICUSPID REGURGITATION AND PERICARDIAL TAMPONADE WITH A SECONDARY DIAGNOSIS OF RIGHT AND LEFT PNEUMOTHORAX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A DEVICE AND VENTRICULAR LEAD IMPLANT, HOWEVER THE ATRIAL LEAD WAS NOT ABLE TO BE IMPLANTED AS THE PATIENT COMPLAINED OF CHEST PAINS. FLUOROSCOPY SHOWED POSSIBLE FLUID IN THE PERICARDIAL SAC AND PARACARDIOCENTESIS WAS ATTEMPTED. THE PATIENT WAS TAKED TO SURGERY AT THAT TIME. THE NEXT DAY, THE MANUFACTURER'S REPRESENTATIVE CHECKED THE DEVICE AND NOTED THE VENTRICULAR LEAD DID NOT CAPTURE AND APPEARED TO HAVE DISLODGED DUE TO THE OPEN HEART SURGERY. THE PATIENT WAS NOT PACER DEPENDENT. THE PATIENT DIED FOUR DAYS AFTER THE IMPLANT. THE PHYSICIAN DOES NOT SUSPECT THE LEADS OR DEVICE IN THE PATIENT'S DEATH. THE PATIENT IS REPORTED TO HAVE HAD MULTIPLE CONCOMMITANT MEDICAL PROBLEMS. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A DEVICE AND VENTRICULAR LEAD IMPLANT, HOWEVER THE ATRIAL LEAD WAS NOT ABLE TO BE IMPLANTED AS THE PATIENT COMPLAINED OF CHEST PAINS. FLUOROSCOPY SHOWED POSSIBLE FLUID IN THE PERICARDIAL SAC AND PARACARDIOCENTESIS WAS ATTEMPTED. THE PATIENT WAS TAKED TO SURGERY AT THAT TIME. NEXT DAY, MANUFACTURER'S REPRESENTATIVE CHECKED DEVICE AND NOTED VENTRICULAR LEAD DID NOT CAPTURE AND APPEARED TO HAVE DISLODGED DUE TO THE OPEN HEART SURGERY. PATIENT WAS NOT PACER DEPENDENT AND DIED FOUR DAYS AFTER IMPLANT. PHYSICIAN DOES NOT SUSPECT LEADS OR DEVICE IN PATIENT'S DEATH. PATIENT IS REPORTED TO HAVE HAD MULTIPLE CONCOMMITANT MEDICAL PROBLEMS. CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH CLINIC REPORTED THAT PER HOSPITAL RECORDS, THE PATIENT HAD CODED WITH SECOND DEGREE HEART BLOCK AND NEAR SYNCOPE. NOTED TRICUSPID REGURGITATION AND PERICARDIAL TAMPONADE WITH A SECONDARY DIAGNOSIS OF RIGHT AND LEFT PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SESR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| O