BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA DR

    MDR report key: 1711518 · Received June 7, 2010

    Report

    Report Number
    6000144-2010-02048
    Event Type
    Death
    Date Received
    June 7, 2010
    Date of Event
    March 31, 2010
    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
    NC
    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B) (4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B) (4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    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 DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (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 DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B) (4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED WITH CAUSE OF DEATH NOTED TO BE CARDIOPULMONARY ARREST, SEPSIS, CLOSTRIDIUM DIFFICILE ENTERITIS, DECREASED IMMUNITY DUE TO AGE AND ANTIBIOTIC TREATMENT, DEMENTIA, RENAL INSUFFICIENCY, CORONARY ARTERY DISEASE, AND GERD. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED WITH CAUSE OF DEATH NOTED TO BE CARDIOPULMONARY ARREST, SEPSIS, CLOSTRIDIUM DIFFICILE ENTERITIS, DECREASED IMMUNITY DUE TO AGE AND ANTIBIOTIC TREATMENT, DEMENTIA, RENAL INSUFFICIENCY, CORONARY ARTERY DISEASE, AND GERD. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CLINIC LAST CHECKED THE DEVICE ON (B) (6) 2010, AND EVERYTHING CHECKED OUT FINE. THE PATIENT WAS PACEMAKER DEPENDENT. THE FAMILY HAD REQUESTED THE DEVICE BE TURNED OFF ON (B) (6) 2010.

    Description of Event or Problem · 1

    (B) (4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Death