BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 1990524 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00740
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES FOUND.

    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 EXPERIENCED PALPITATIONS AND THAT THERE WAS DIFFICULTY PROGRAMMING THE DEVICE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PALPITATIONS AND THAT THERE WAS DIFFICULTY PROGRAMMING THE DEVICE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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 26 YR Other 5071 IMPLANTABLE PACING LEAD| 4951M IMPLANTABLE PACING LEAD| 4951M IMPLANTABLE PACING LEAD| 5071 IMPLANTABLE PACING LEAD