BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 5712235 · Received June 9, 2016

    Report

    Report Number
    2182208-2016-01501
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    December 1, 2015
    Report Date
    March 3, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    1-CARD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. MULTIPLE PATIENTS AND MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. THE PMA NUMBER FOR THIS REPORT LISTED IS PART OF A COMBINATION OF PMAS CONSIDERED THE "1-CARD" AND CONSISTS OF P820003, P850051, P890003, P930022, P970012 AND P980035. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: PACEMAKER-MEDIATED TACHYCARDIA: MANUFACTURER SPECIFICS AND SPECTRUM OF CASES. PACE PACING AND CLINICAL ELECTROPHYSIOLOGY. 2015;38(12):1489-1498.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING IMPLANTABLE PULSE GENERATORS (IPGS). MULTIPLE PATIENTS AND MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT THERE WERE ISSUES OF ATRIAL CAPTURE FAILURE, FAR-FIELD OVERSENSING, AND MISSING DEVICE DETECTION EPISODES SEEN WITH THE IPGS. THE ALGORITHM FOR DETECTING THESE TYPES OF EPISODES IS PROGRAMMED OFF AND THE ARTICLE SUGGESTS THAT IT BE PROGRAMMED ON AT IMPLANTATION TIME. THE STATUS OF THE IPGS IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367702 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention