BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 2813335 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06479
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 12, 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
    IL, 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: (B)(4): THE DEVICE WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, A SET SCREW WAS MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT THE PHYSICIAN ATTEMPTED TO SCREW THE SET SCREW FOR THE RIGHT VENTRICULAR (RV) PORT AND IT WOULD NOT TIGHTEN. THE DEVICE WAS NOT USED AND WAS REPLACED. 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. ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other