BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA SR

    MDR report key: 3160413 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10093
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    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
    NC, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED THE SET SCREW WAS FOUND IN THE CONNECTOR BORE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PATIENT CODED AND BECAME PACEMAKER DEPENDENT. THE PHYSICIAN ATTEMPTED TO MOVE THE LEAD FROM THE ANALYZER CABLES TO THE DEVICE, BUT WAS NOT ABLE TO SECURE THE LEAD IN THE DEVICE HEADER CAUSING SIGNIFICANT ASYSTOLE. THE PHYSICIAN MOVED THE LEAD BACK TO THE ANALYZER CABLES. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259330 ADAPTA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADSR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| L| R