BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 1922990 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-06023
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 16, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CHRONIC COMPETITOR ATRIAL LEAD WAS CONNECTED TO THE DEVICE AT IMPLANT, THERE WAS NO OUTPUT. THE LEAD WAS RECONNECTED AND THERE WAS ATRIAL CAPTURE. ONE DAY AFTER IMPLANT, THERE WAS NO ATRIAL CAPTURE. THE ATRIAL LEAD WAS CAPPED AND A NEW COMPETITOR LEAD WAS IMPLANTED. THERE WAS NO ATRIAL OUTPUT WITH THE NEW LEAD. THE DEVICE WAS REMOVED AND REPLACED. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R 4467 COMPETITOR IMPLANTABLE PACING LEAD| 1488TC COMPETITOR IMPLANTABLE PACING LEAD