BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 2952030 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01677
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: 5034 IMPLANTABLE PACING LEAD (B)(6) 1997. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO PACING NOTED DURING CHEST SURGERY, DESPITE THE MAGNET BEING TAPED OVER TOP OF THE DEVICE. FOLLOW UP DETERMINED THAT THE PROGRAMMER SESSION WAS NOT ENDED PRIOR TO THE PATIENT BEING TAKEN TO THE OPERATING ROOM. 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
    55770 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR 4524 IMPLANTABLE PACING LEAD