BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA SR

    MDR report key: 2001705 · Received February 25, 2011

    Report

    Report Number
    2647346-2011-00217
    Event Type
    Death
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 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.

    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, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S SPOUSE THAT PATIENT WAS IN A SINGLE VEHICLE ACCIDENT WHILE DRIVING TRUCK AND DIED. "HE FOR SOME REASON WENT OFF THE ROAD AND WENT OVER 700 FT. AND WAS KILLED." SPOUSE FURTHER REPORTS THE CORONER COULD ONLY FIND BLUNT FORCE TRAUMA AS THE CAUSE OF DEATH, "BUT SUGGEST WE HAVE HIS PACEMAKER CHECK TO SEE IF IT WAS OPERATING CORRECTLY AT THE TIME." ADDITIONAL INFORMATION IS BEING REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S SPOUSE THAT PATIENT WAS IN A SINGLE VEHICLE ACCIDENT WHILE DRIVING TRUCK AND DIED. "HE FOR SOME REASON WENT OFF THE ROAD AND WENT OVER 700 FT. AND WAS KILLED." SPOUSE FURTHER REPORTS THE CORONER COULD ONLY FIND BLUNT FORCE TRAUMA AS THE CAUSE OF DEATH, "BUT SUGGEST WE HAVE HIS PACEMAKER CHECK TO SEE IF IT WAS OPERATING CORRECTLY AT THE TIME." ADDITIONAL INFORMATION IS BEING REQUESTED. IT WAS UNKNOWN IF THE PATIENT HAD BEEN PACEMAKER DEPENDENT. PATIENT'S DAUGHTER LATER REPORTED REGARDING DEVICE ANALYSIS "WILL THIS SHOW IF PM WAS FAULTY? SOMETHING HAPPENED TO MY DAD THE DAY OF HIS CAR ACCIDENT AND WE NEED ANSWERS."

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S SPOUSE THAT PATIENT WAS IN A SINGLE VEHICLE ACCIDENT WHILE DRIVING TRUCK AND DIED. "HE FOR SOME REASON WENT OFF THE ROAD AND WENT OVER 700 FT. AND WAS KILLED." SPOUSE FURTHER REPORTS THE CORONER COULD ONLY FIND BLUNT FORCE TRAUMA AS THE CAUSE OF DEATH, "BUT SUGGEST WE HAVE HIS PACEMAKER CHECK TO SEE IF IT WAS OPERATING CORRECTLY AT THE TIME." ADDITIONAL INFORMATION IS BEING REQUESTED. IT WAS UNKNOWN IF THE PATIENT HAD BEEN PACEMAKER DEPENDENT.

    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 69 YR Death