BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 1861727 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04743
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE PATIENT WENT TO THE EMERGENCY ROOM BECAUSE THEY FELT AN INTERMITTENT "SHOCKING SENSATION AT THE PACEMAKER SITE", THAT STARTED 3 DAYS PRIOR. THE DEVICE WAS INTERROGATED. TESTED, AND MEASUREMENTS LOOKED GOOD; REPROGRAMMING OUTPUTS OR POLARITY COULD NOT REPLICATE THE SENSATION. IT WAS ALSO REPORTED THAT THE PATIENT FELT SOMETHING DURING THE DEVICE TEST, BUT IT WASN'T THE SAME "SHOCKING SENSATION". WHEN THE PATIENT SAID THEY FELT THE SHOCKING, THE DEVICE MANUFACTURER REPRESENTATIVE COULD NOT SEE NOR FEEL ANY MOVEMENT ON THE PATIENT'S CHEST. 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. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 5076 (X2) IMPLANTABLE PACING LEAD