BEUDAMED
    FDA Adverse Event Death Summary report: N

    N/A

    MDR report key: 2864031 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11362
    Event Type
    Death
    Date Received
    December 10, 2012
    Date of Event
    October 14, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. PRODUCT EVENT SUMMARY (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4). CONCOMITANT PRODUCT: 4592 IMPLANTABLE PACING LEAD (B)(6) 2005.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. THE LEADS WERE ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT IS DECEASED. ADDITIONAL INFORMATION OBTAINED NOTED THE PATIENT DIED OF ACUTE RESPIRATORY FAILURE AND ACUTE ENDOCARDITIS. INFORMATION OBTAINED FROM THE CLINIC NOTED THAT THE PATIENT HAD SUSTAINED A FALL THREE MONTHS PRIOR TO PATIENT DEATH AND HAD BRUISING BEHIND BOTH EARS. THE DEVICE WAS CHECKED AND REVEALED NORMAL DEVICE FUNCTION. ADDITIONAL INFORMATION RELATED TO THE CIRCUMSTANCES OF PATIENT DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death 4092 IMPLANTABLE PACING LEAD