BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 2813351 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06261
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 27, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. EVALUATION SUMMARY FOR: (B)(4) - THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE SET SCREW WAS MISSING A PART.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INITIALLY, DURING THE PROCEDURE, THE LEADS WERE REVERSED IN THE HEADER OF THE DEVICE. WHEN THE PHYSICIAN REMOVED THE LEADS FROM THE HEADER TO REINSERT THEM CORRECTLY, ONE OF THE SETSCREWS CAME OUT OF THE DEVICE. THE DEVICE WAS NOT USED. A NEW 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 DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other