BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA SR

    MDR report key: 2111194 · Received June 2, 2011

    Report

    Report Number
    6000094-2011-00687
    Event Type
    Death
    Date Received
    June 2, 2011
    Date of Event
    May 11, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ADDITIONAL INFORMATION HAS BEEN REQUESTED INCLUDING THE OFFICIAL CAUSE OF DEATH AND NOT YET RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED DUE TO CARDIAC ARREST. NO ALLEGATIONS, COMPLAINTS, OR SUSPICIONS HAVE BEEN MADE AGAINST THE IMPLANTABLE PULSE GENERATOR. FURTHER INFORMATION AND OFFICIAL CAUSE OF DEATH HAVE BEEN REQUESTED AND NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. ADSR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Death| H| L| R