BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 2951495 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01554
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 26, 2012
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH SYNCOPE AND BECAME FEBRILE, AND FOUND THAT THE PATIENT HAD STAPH BACTEREMIA INFECTION. IT WAS NOTED BY THE PHYSICIAN THAT THE DEVICE POCKET APPEARED NORMAL AND THERE WAS NO VEGETATION ON THE LEAD. IT WAS ALSO NOTED THAT THE PATIENT HAD THE SAME INFECTION PREVIOUSLY, PRIOR TO THE DEVICE SYSTEM WAS IMPLANTED. THE LEADS AND DEVICE WERE REMOVED, AND ANTIBIOTIC TREATMENT PRESCRIBED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57159 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO VEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R 5076 X2 IMPLANTABLE PACING LEADS