BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 3860366 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10571
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-2120-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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. THIS DEVICE WAS INCLUDED IN A FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF EITHER THE PRODUCT OR PERFORMANCE DATA, OR COMPLETION OF ANALYSIS, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT PRODUCTS: 1346T COMPETITOR LEAD, IMPLANTED: (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT WHILE IN THE PROCESSING OF SHUTTING DOWN A LAPTOP COMPUTER, THE PATIENT PICKED UP THE COMPUTER AND PUT IT NEAR THEIR HEART AND THEN "FELT A CHANGE, SIMILAR TO WHEN THEY DO A DEVICE CHECK BUT NOT QUITE LIKE THIS, IN FACT, I DROPPED MY LAPTOP BECAUSE OF IT." 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
    342219 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR 1388T COMPETITOR LEAD