BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 4160057 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19154
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) ONLY LASTED ONE YEAR DUE TO HIGH ATRIAL OUTPUTS AND DID NOT MEET EXPECTED LONGEVITY. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD THRESHOLDS HAD BEEN CLIMBING OVER TIME TO THE POINT THAT THERE WAS CAPTURE ONLY AT MAXIMUM OUTPUT. THE LEAD WAS CAPPED AND NOT REPLACED, AND THE DEVICE WAS EXPLANTED AND REPLACED BY A SINGLE CHAMBER SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637950 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R 5076-45 LEAD, 5076-52 LEAD