BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 3071650 · Received April 22, 2013

    Report

    Report Number
    9614453-2013-01022
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4) IMPLANTABLE PACING LEAD 2008 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A RRT (RECOMMENDED REPLACEMENT TIME) LOCKUP CONDITION THAT PREVENTS DEVICE PROGRAMMING. MEASUREMENT SYSTEM LOCK-UP ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED A POWER ON RESET (POR). IT WAS NOTICED THAT THE DEVICE WAS IN VVI MODE. THE DEVICE WAS REPROGRAMMED AND PARAMETERS WERE RESTORED TO DDDR. THE PATIENT EXPERIENCED SHORTNESS OF BREATH SINCE THE RESET OCCURRED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171440 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention (B)(4) IMPLANTABLE PACING LEAD