BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA SR

    MDR report key: 2014206 · Received March 10, 2011

    Report

    Report Number
    2647346-2011-00239
    Event Type
    Death
    Date Received
    March 10, 2011
    Date of Event
    February 8, 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
    US
    Reporter Occupation
    OTHER

    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. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND.

    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. 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 NOTED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS FOLLOWING DEVICE SYSTEM IMPLANT. CAUSE OF DEATH INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS FOLLOWING DEVICE SYSTEM IMPLANT. CAUSE OF DEATH INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH THE NURSE IN THE CLINIC REPORTED SHE HAD NO CAUSE OF DEATH INFORMATION, BUT COULD REPORT THAT THERE HAD BEEN NO DEVICE OR LEAD ISSUES PRIOR TO DEATH.

    Description of Event or Problem · 1

    ASKU

    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 80 YR Death