BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 3050981 · Received April 10, 2013

    Report

    Report Number
    3008973940-2013-00057
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    January 3, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE IMPLANTABLE PULSE GENERATOR (IPG) WAS RETURNED TO THE MANUFACTURER. ANALYSIS REVEALED NO ANOMALIES WERE FOUND. (B)(4).

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT PACING PROPERLY WHEN IN UNIPOLAR OR BIPOLAR. THE LEADS WERE ATTACHED TO A NEW DEVICE AND SYSTEM PACED APPROPRIATELY. IT WAS LATER REPORTED THAT THE IPG ALSO HAD A SENSING ISSUE AND THAT THE IPG WAS IMPLANTED AND WAS EXPLANTED AND REPLACED AT A LATER DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT PACING PROPERLY WHEN IN UNIPOLAR OR BIPOLAR. THE LEADS WERE ATTACHED TO A NEW DEVICE AND SYSTEM PACED APPROPRIATELY. ADDITIONAL INFORMATION WAS ATTEMPTED TO BE OBTAINED REGARDING WHETHER OR NOT THIS WAS AN IMPLANT ATTEMPT OR IF THE IPG WAS EXPLANTED AND REPLACED. THE INFORMATION WAS NOT AVAILABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151853 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS ADDR01 NWB019839G

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R