BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2812233 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02605
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. FAILURE DISAPPEARED DURING ANALYSIS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS IN THE EMERGENCY DEPARTMENT (ED) WITH A LOW HEART RATE AND LOOKING PALE. PER CALLER, THEY CANNOT INTERROGATE DEVICE, "CANNOT DOWNLOAD". THE NURSE HAS USED SEVERAL PROGRAMMERS AND HAS CHANGED THE PROGRAMMING HEAD. TWIDDLER'S SYNDROME WAS SUSPECTED. NO PACING RESPONSE WITH PROGRAMMING HEAD. THE PATIENT HAS A HISTORY OF HIGH OUTPUTS. THE DEVICE HAS REACHED END OF LIFE (EOL) AND WILL BE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS IN THE EMERGENCY DEPARTMENT (ED) WITH A LOW HEART RATE AND LOOKING PALE. PER CALLER, THEY CANNOT INTERROGATE DEVICE, "CANNOT DOWNLOAD". THE NURSE HAS USED SEVERAL PROGRAMMERS AND HAS CHANGED THE PROGRAMMING HEAD. TWIDDLER'S SYNDROME WAS SUSPECTED. NO PACING RESPONSE WITH PROGRAMMING HEAD. THE PATIENT HAS A HISTORY OF HIGH OUTPUTS. THE DEVICE HAS REACHED END OF LIFE (EOL) AND WILL BE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC S.A. ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R