BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA

    MDR report key: 2970466 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-02921
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 25, 2013
    Report Date
    April 20, 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
    TX, 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: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    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 EXPLANT PROCEDURE FOR NORMAL BATTERY DEPLETION, A WHITISH/YELLOWISH SUBSTANCE WAS NOTED ON THE TERMINAL PIN OF THE RIGHT ATRIAL LEAD. CULTURE OF THE SUBSTANCE WAS NEGATIVE AND THE LEAD REMAINED IN USE. THE DEVICE WAS REMOVED AND REPLACED AND IT WAS REPORTED THERE WAS A POSSIBLE CRACK IN THE HEADER OF THE DEVICE. THE PHYSICIAN NOTED THE FLUID WAS THOUGHT TO BE A FOREIGN BODY TYPE REACTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EXPLANT PROCEDURE FOR NORMAL BATTERY DEPLETION, A WHITISH/YELLOWISH SUBSTANCE WAS NOTED ON THE TERMINAL PIN OF THE RIGHT ATRIAL LEAD. CULTURE OF THE SUBSTANCE WAS NEGATIVE AND THE LEAD REMAINED IN USE. THE DEVICE WAS REMOVED AND REPLACED AND IT WAS REPORTED THERE WAS A POSSIBLE CRACK IN THE HEADER OF THE DEVICE. THE PHYSICIAN NOTED THE FLUID WAS THOUGHT TO BE A FOREIGN BODY TYPE REACTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74290 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRS1

    Patients

    Seq Age Sex Outcome Treatment
    1 00005 YR Hospitalization| R 4968 IMPLANTABLE PACING LEAD X2