BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENPULSE DR

    MDR report key: 2964436 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02733
    Event Type
    Death
    Date Received
    February 15, 2013
    Date of Event
    January 3, 2013
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 INFORMATION NOTED THERE WAS POSSIBLE LEFT ANTERIOR DESCENDING ARTERY OCCLUSION. (B)(4). CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD, (B)(6) 2005.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND NOTED THAT THE POSTMORTEM INVESTIGATION INCLUDING AUTOPSY SHOWED KNOWN CHRONIC CORONARY ARTERY DISEASE BUT NO ACUTE MYOCARDIAL INFARCTION OR OTHER DEFINITIVE CAUSE OF DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED. IT WAS FURTHER REPORTED THAT THE PATIENT DIED TWO DAYS PRIOR TO PLANNED DEVICE REPLACEMENT PROCEDURE AND THERE IS POSSIBLE PREMATURE BATTERY DEPLETION AND HIGH BATTERY IMPEDANCE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PHYSICIAN NOTED POSSIBLE LOSS OF PACING OUTPUT AND NON-CAPTURE. THE CAUSE OF DEATH HAS NOT BEEN CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED. IT WAS FURTHER REPORTED THAT THE PATIENT DIED TWO DAYS PRIOR TO PLANNED DEVICE REPLACEMENT PROCEDURE AND THERE IS POSSIBLE PREMATURE BATTERY DEPLETION AND HIGH BATTERY IMPEDANCE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PHYSICIAN NOTED POSSIBLE LOSS OF PACING OUTPUT AND NON-CAPTURE. THE CAUSE OF DEATH HAS NOT BEEN CONCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67775 ENPULSE DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO E2DR01AA

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death 4075 IMPLANTABLE PACING LEAD