BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA SR

    MDR report key: 3993106 · Received August 8, 2014

    Report

    Report Number
    3008973940-2014-00315
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV (RIGHT VENTRICULAR) LEAD DISLODGED. THE LEAD WAS REPOSITIONED. WHEN THE LEAD WAS BEING RECONNECTED, THERE WAS NO PACING. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEAD REMAINS IN USE. IT WAS LATER DETERMINED THAT THE CAUSE OF THE PACING FAILURE WAS DUE TO OPERATION IN UNIPOLAR, WITH THE DEVICE OUTSIDE THE POCKET. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472266 ADAPTA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS ADSR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R 5076-58 LEAD