BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA SR

    MDR report key: 1712609 · Received June 8, 2010

    Report

    Report Number
    2647346-2010-00179
    Event Type
    Death
    Date Received
    June 8, 2010
    Date of Event
    November 6, 2009
    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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT AND THEY WERE TOLD "DEVICE IS NOT WORKING PROPERLY BUT SHE COULD NOT DESCRIBE DETAILS." LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED APPROXIMATELY 5 WEEKS LATER. 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 BY THE PATIENT'S DAUGHTER THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT, AND THEY WERE TOLD "DEVICE IS NOT WORKING PROPERLY, BUT SHE COULD NOT DESCRIBE DETAILS." LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED APPROXIMATELY 5 WEEKS LATER. FOLLOW UP WITH THE PHYSICIAN REPORTED THE CAUSE OF DEATH TO BE SEPSIS AND ENDOCARDITIS. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR SICK SINUS SYNDROME, ATRIAL FIBRILLATION, AND SENILE DEMENTIA. THE PATIENT HAD BEEN PACEMAKER DEPENDENT. NO AUTOPSY WAS PERFORMED. IT IS UNKNOWN TO THE PHYSICIAN IF THE DEATH WAS DEVICE OR LEAD RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADSR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Death| O