BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA

    MDR report key: 2963695 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02699
    Event Type
    Death
    Date Received
    February 15, 2013
    Date of Event
    September 19, 2012
    Report Date
    March 7, 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

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

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). CONCOMITANT MEDICAL PRODUCTS CONTINUED: 5568 IMPLANTABLE PACING LEAD: (B)(6) 2006.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A CREMATORY WITH INFORMATION NOTING THE PATIENT IS DECEASED. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS AFTER DEVICE REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A CREMATORY WITH INFORMATION NOTING THE PATIENT IS DECEASED. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS AFTER DEVICE REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69330 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00096 YR Death 5076 IMPLANTABLE PACING LEAD