BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 2203502 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04423
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 17, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDTRONIC HAD MANUFACTURED A CUSTOM DEVICE FOR A PATIENT WITH A TITANIUM ALLERGY AT THE REQUEST OF A PHYSICIAN. THIS DEVICE, INCLUDING THE CAN AND HEADER, HAD BEEN 100% COATED WITH PARYLENE. A DEVICE THAT IS 100% COATED WILL NOT FUNCTION IN UNIPOLAR MODE. THIS CUSTOM DEVICE WAS IMPLANTED IN A PATIENT OTHER THAN THE PATIENT IT WAS REQUESTED FOR. THE DEVICE CONTINUES TO FUNCTION IN BIPOLAR MODE, THE PATIENT IS NOT PACING DEPENDENT, THE PHYSICIAN PROGRAMMED THE DEVICE IN BIPOLAR MODE, AND THE IMPLANTING PHYSICIAN IS AWARE THE DEVICE WILL NOT FUNCTION IN UNIPOLAR MODE. 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
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDRL1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other 4076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD