BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO VR

    MDR report key: 1944507 · Received January 3, 2011

    Report

    Report Number
    2647346-2011-00002
    Event Type
    Death
    Date Received
    January 3, 2011
    Date of Event
    December 16, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, DISTAL AND DEFIB CONDUCTORS DISTORTED, SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), INNER TUBING KINKED/BUCKLED, OUTER INSULATION COSMETIC CUT, ALL INSULATORS BREACHED CUT, HELIX/LOBE DISTORTED/BENT, BLOOD IN/ON HELIX/LOBE MECHANISM, APPARENT EXPLANT DAMAGE. FULL LEAD RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    ASKU

    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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B)(4) 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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT DIED AND "THERE WAS A QUESTION ABOUT HIS HEART RATE AT THE TIME OF HIS DEATH AND WE WANT TO GET THE DEVICE CHECKED." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT DIED AND "THERE WAS A QUESTION ABOUT HIS HEART RATE AT THE TIME OF HIS DEATH AND WE WANT TO GET THE DEVICE CHECKED." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. IT WAS LATER REPORTED THAT, ACCORDING TO THE CLINICIANS, THE DEVICE IS NOT SUSPECT IN THE PATIENT'S DEATH. FOLLOW UP LATER REPORTED THE PATIENT'S FAMILY QUESTIONED "WHETHER THERE WAS A DEVICE MALFUNCTION CAUSING HIS COLLAPSE."

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT DIED AND "THERE WAS A QUESTION ABOUT HIS HEART RATE AT THE TIME OF HIS DEATH AND WE WANT TO GET THE DEVICE CHECKED." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. IT WAS LATER REPORTED THAT, ACCORDING TO THE CLINICIANS, THE DEVICE IS NOT SUSPECT IN THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    PATIENT'S DAUGHTER REPORTED PATIENT DIED AND "THERE WAS A QUESTION ABOUT HIS HEART RATE AT THE TIME OF HIS DEATH AND WE WANT TO GET THE DEVICE CHECKED." CAUSE OF DEATH REQUESTED AND NOT RECEIVED. PATIENT'S FAMILY QUESTIONED "WHETHER THERE WAS A DEVICE MALFUNCTION CAUSING HIS COLLAPSE." LATER REPORTED THAT, ACCORDING TO CLINICIANS, DEVICE IS NOT SUSPECT IN PATIENT'S DEATH. PATIENT DISCHARGED FROM HOSPITAL TO NURSING FACILITY 13 DAYS PRIOR TO DEATH. LAST OFFICE VISIT WAS FIVE DAYS AFTER HOSPITAL DISCHARGE. AN ECHOCARDIOGRAM SHOWED EJECTION FRACTION OF 30%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7232CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death