BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 3993862 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14566
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. PRODUCTS: 5076-45 LEAD IMPLANTED: 2006 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG), THERE WAS NO OUTPUT WHEN THE LEADS WERE CONNECTED TO THE IPG. THE LEAD WAS MANUALLY PROGRAMMED TO BIPOLAR. THE LEADS HAD TESTED FINE THROUGH THE ANALYZER. THE PHYSICIAN STATED THE SETSCREW FELT "SQUISHY" UNTIL THE TORQUE WRENCH BEGAN TO CLICK. VISUAL INSPECTION SHOWED THE PIN WAS SEATED PROPERLY IN THE PORT, AND IT WOULD NOT UNSEAT FROM TUGGING. WHEN THE LEAD WAS TAKEN OUT OF THE DEVICE AND RECONNECTED TO THE ANALYZER, PACING WAS APPROPRIATE. THE IPG WAS NOT IMPLANTED; THE LEADS WERE CONNECTED TO ANOTHER DEVICE WITHOUT INCIDENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469400 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR 5076-52 LEAD