BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEO LEGACY

    MDR report key: 7134425 · Received December 20, 2017

    Report

    Report Number
    3007972010-2017-00003
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    October 30, 2017
    Report Date
    November 21, 2017
    Manufacturer
    CVRX, INC.
    Product Code
    DSR
    UDI-DI
    00859144004210
    PMA / PMN Number
    H130007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE INCLUDED THE IPG (SERIAL NUMBER (B)(4)) AND PART OF THE RIGHT LEAD (SERIAL NUMBER (B)(4)). THERE WERE NO ANOMALIES FOUND WITH THE IPG, AND IT WAS FUNCTIONING AS INTENDED WHEN ANALYZED. THE PORTION OF THE LEAD RETURNED INCLUDED A SECTION WITH THE SERIAL NUMBER AND A STRETCHED OUT SECTION OF THE COIL. THE LEAD WAS RETURNED IN TWO SECTIONS. THE AREA OF THE LEAD THAT WAS FRACTURED DUE TO THE DESIGN ISSUE WAS NOT RETURNED.

    Description of Event or Problem · 1

    A DOUBLE LEAD REPAIR WAS DONE AT (B)(6) ON (B)(6) 2017 DURING A NORMAL IPG REPLACEMENT. IPG (B)(4) WAS REPLACED WITH (B)(4). THE RIGHT LEAD WAS SEVERED, AND THE TERMINAL PIN WAS MISSING SO THAT LEAD WAS FIXED FIRST. DR. (B)(6) SUCCESSFULLY REPAIRED THE LEAD RESULTING IN AN IMPEDANCE OF 349. NEO LEAD REPAIR KIT (B)(4) WAS USED TO REPAIR THE RIGHT LEAD. THE OUTER COIL ON THE LEFT LEAD WAS STRETCHED OUT BETWEEN THE TERMINAL PIN AND TUBING AROUND THE LEAD SERIAL NUMBER LABEL, BUT IT STILL SHOWED GOOD CONNECTIVITY WITH AN IMPEDANCE OF 377. TO REINFORCE THIS SECTION OF THE LEAD, DR. (B)(6) PUT A TUBE AROUND THIS PORTION AND FILLED IT WITH SILICONE ADHESIVE. THE FINAL IMPEDANCE FOR THE LEFT LEAD WAS 376. THE PATIENT HAD NOT BEEN EXPERIENCING ANY SYMPTOMS LEADING UP TO THE IPG REPLACEMENT AND LEAD REPAIRS.

    Description of Event or Problem · 1

    A DOUBLE LEAD REPAIR WAS DONE AT (B)(6) ON (B)(6) 2017 DURING A NORMAL IPG REPLACEMENT. IPG (B)(4) WAS REPLACED WITH (B)(4). THE RIGHT LEAD WAS SEVERED, AND THE TERMINAL PIN WAS MISSING, SO THAT LEAD WAS FIXED FIRST. DR. (B)(6) SUCCESSFULLY REPAIRED THE LEAD RESULTING IN AN IMPEDANCE OF 349. NEO LEAD REPAIR KIT (B)(4) WAS USED TO REPAIR THE RIGHT LEAD. THE OUTER COIL ON THE LEFT LEAD WAS STRETCHED OUT BETWEEN THE TERMINAL PIN AND TUBING AROUND THE LEAD SERIAL NUMBER LABEL, BUT IT STILL SHOWED GOOD CONNECTIVITY WITH AN IMPEDANCE OF 377. TO REINFORCE THIS SECTION OF THE LEAD, DR. (B)(6) PUT A TUBE AROUND THIS PORTION AND FILLED IT WITH SILICONE ADHESIVE. THE FINAL IMPEDANCE FOR THE LEFT LEAD WAS 376. THE PATIENT HAD NOT BEEN EXPERIENCING ANY SYMPTOMS LEADING UP TO THE IPG REPLACEMENT AND LEAD REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914057 NEO LEGACY IMPLANTABLE PULSE GENERATOR DSR CVRX, INC. 2100 00859144004210

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention