BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 1792467 · Received August 11, 2010

    Report

    Report Number
    6000144-2010-03262
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    May 7, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    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

    THE PATIENT REPORTED EXPERIENCING "GREAT PAIN ON MY RIGHT SIDE." THE PATIENT WAS TO FOLLOW-UP WITH PHYSICIAN. THE DEVICE IS STILL IN USE. NO FURTHER 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other 5092 IMPLANTABLE PACING LEAD| 5592 IMPLANTABLE PACING LEAD| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6996 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD