BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2811831 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06192
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THE DEVICE WAS NOT MODE SWITCHING PROPERLY. IT WAS INDICATED THAT THE PATIENT WAS SYMPTOMATIC WITH ATRIAL TACHYCARDIA, BUT THE DEVICE LISTED NO EPISODES. ALSO, THE ATRIAL LEAD MAY HAVE BEEN UNDERSENSING P-WAVES AND THAT DURING THE SLOW ATRIAL TACHYCARDIA THE P-WAVES WERE TOO SMALL TO SENSE. THE DEVICE HISTORY ALSO HAD A SIMILAR EPISODE THE PRIOR YEAR WHERE THE DEVICE DID NOT MODE SWITCH. THE SENSITIVITY WAS GOING TO BE INCREASED AND THE DEVICE AND LEAD REMAIN 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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 4076 IMPLANTABLE PACING LEAD