BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 2865079 · Received December 10, 2012

    Report

    Report Number
    3008973940-2012-00053
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 12, 2012
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE OF THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVENT SUMMARY (B)(4): THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE SET SCREW SOCKET WAS ROUNDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO CONNECT THE LEAD TO THE VENTRICULAR PORT OF THE DEVICE, THEY DID NOT HEAR THE "CLICKING" SOUND WHEN TRYING TO TIGHTEN THE SETSCREW, AND THE LEAD WAS NOT ABLE TO BE REMOVED BY PULLING ON IT. THE PHYSICIAN REMOVED AND ATTEMPTED TO RECONNECT THE LEAD; HOWEVER, THE DEVICE SETSCREW DISENGAGED. THE DEVICE WAS REMOVED AND A DIFFERENT DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR