BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 2529140 · Received April 11, 2012

    Report

    Report Number
    6000144-2012-02039
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Date of Event
    January 24, 2012
    Report Date
    June 22, 2021
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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
    CA, 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 LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WERE INDICATIONS THAT THE LEAD MAY NOT HAVE BEEN FULLY SEATED IN THE HEADER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SLS STUDY THAT DURING IMPEDANCE TESTING LOSS OF CAPTURE ON THE VENTRICULAR LEAD WAS NOTED. THE PATIENT HAD ALSO SWITCHED TO UNIPOLAR CONFIGURATION ON THE VENTRICULAR LEAD. THE DEVICE WAS REPROGRAMMED, BUT THE PATIENT ALSO HAD AN X-RAY. IT WAS DETERMINED THAT THE LEAD WAS NOT IN THE DEVICE HEADER ALL THE WAY. THE PATIENT UNDERWENT A PROCEDURE TO RE-INSERT THE LEAD INTO THE HEADER. THE LEAD AND DEVICE REMAIN IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R 5568 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD