BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA

    MDR report key: 2970432 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-02919
    Event Type
    Death
    Date Received
    February 20, 2013
    Date of Event
    March 10, 2008
    Report Date
    May 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    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. NO FURTHER INFORMATION WILL BE OBTAINED DUE TO INFORMATION TO COMPLETE THE FOLLOW-UP IS NOT REASONABLY KNOWN WITH THE DATE OF DATE GREATER THAN TWO YEARS AGO. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: 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.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED FROM (B)(4) CREMATORY WITH LIMITED INFORMATION. INFORMATION IDENTIFIED IN THE PAPERWORK INDICATED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS POST IMPLANT OF THE IPG SYSTEM APPROXIMATELY FOUR YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74458 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Death 5076 IMPLANTABLE PACING LEAD