BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENPULSE

    MDR report key: 1721148 · Received June 11, 2010

    Report

    Report Number
    6000144-2010-02458
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    May 18, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S032
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 MANUFACTURER REPRESENTATIVE ON 24-MAR-2010, THE DEVICE WAS AT ERI (ELECTIVE REPLACEMENT INDICATOR) YET BATTERY VOLTAGE WAS AT 2.73 VOLTS AND 2678 OHMS. THE DEVICE WAS PROGRAMMED BACK TO PREVIOUS SETTINGS. LATER REVIEW OF MANUFACTURER'S DATABASE, REVEALED THE PATIENT DIED (B)(6) 2010. BASED ON FOLLOW-UP, THE PATIENT WAS LAST SEEN BY THE PHYSICIAN IN THE CLINIC IN (B)(6) 2008. 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 THE DEVICE WAS AT ERI (ELECTIVE REPLACEMENT INDICATOR) YET BATTERY VOLTAGE WAS AT 2.73 VOLTS AND 2678 OHMS. THE DEVICE WAS PROGRAMMED BACK TO PREVIOUS SETTINGS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPULSE IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. E2DR21 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| O