BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 2951489 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01543
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 4, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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). CONCOMITANT PRODUCT: (B)(4), IMPLANTABLE PACING LEAD, (B)(6) 2002. EVENT SUMMARY: (B)(4)-THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED ENDOCARDITIS. THE DEVICE AND LEADS WERE REMOVED, THE DEVICE POCKET CULTURED AND ANTIBIOTIC TREATMENT WAS "NECESSARY." THE DEVICE WILL BE RETURNED, THE LEADS WILL NOT. NO FU RTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57157 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD