BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA

    MDR report key: 3002060 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03637
    Event Type
    Death
    Date Received
    March 13, 2013
    Date of Event
    November 2, 2012
    Report Date
    April 9, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #EVALUATION SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED WITH NO INFORMATION. A SEARCH BY SERIAL NUMBER REVEALED THE PATIENT TO BE DECEASED. THE DEATH OCCURRED LESS THAN ONE YEAR AFTER IMPLANT. FOLLOW UP FOR INFORMATION WAS INCONCLUSIVE. NO SPECIFIC COMPLAINTS HAVE BEEN MADE AGAINST THE DEVICE SYSTEM. FURTHER INFORMATION WAS REQUESTED AND NOT YET MADE AVAILABLE.

    Description of Event or Problem · 1

    THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED WITH NO INFORMATION . A SEARCH BY SERIAL NUMBER REVEALED THE PATIENT TO BE DECEASED. THE DEATH OCCURED LESS THAN ONE YEAR AFTER IMPLANT. FOLLOW UP FOR INFORMATION WAS INCONCLUSIVE. NO SPECIFIC COMPLAINTS HAVE BEEN MADE AGAINST THE DEVICE SYSTEM. FURTHER INFORMATION WAS REQUESTED AND NOT YET MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105261 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADSR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Death