BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM III

    MDR report key: 3071808 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06719
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE DEVICE WAS RETURNED AND ANALYZED. 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 5076-52 IMPLANTABLE PACING LEAD 2001 (B)(6); 6945 IMPLANTABLE TACHY LEAD 2001 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE INTERROGATED AND WAS AT END OF LIFE (EOL). THE IPG WAS EXPLANTED AND REPLACED. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD HAD NO CAPTURE AND LOW SENSING, THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171480 GEM III DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO 7275

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R