BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 3160406 · Received June 10, 2013

    Report

    Report Number
    3008973940-2013-00096
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. PRODUCT CODE: IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN THE LEAD WAS BEING CONNECTED TO THE DEVICE, NO "TIC" SOUND WAS HEARD WHEN USING A WRENCH TO TIGHTEN THE SETSCREW. THE LEAD WAS THEN ATTEMPTED TO BE DISCONNECTED, AND COULD NOT BE WITH THE FIRST HALF TURN, BUT THEN BECAME DISCONNECTED WITH THE SECOND HALF TURN. THE PHYSICIAN COMMENTED THAT THE CHANNEL OF THE SETSCREW MIGHT BE SHALLOWER THAN USUAL. A DIFFERENT WRENCH WAS USED, THE LEAD WAS SUCCESSFULLY CONNECTED, AND 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
    260272 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS ADDRS1

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR 5076-58 IMPLANTABLE PACING LEAD