BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2954565 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02456
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 9, 2012
    Report Date
    December 9, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVIEWED THAT NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVIEWED THAT NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVIEWED THAT NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BECAME SEPTIC. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  SYSTEM WAS EXPLANTED AND REPLACED AFTER TREATMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59636 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314VRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R