BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 2954390 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02429
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO JUNCOS
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: UPON ANALYSIS, NO ANOMALIES WERE 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. CONCOMITANT MEDICAL PRODUCTS: 5076 IMPLANTABLE PACING LEAD: (B)(6) 2007. BETA BLOCKER, ACE INHIBITOR, WARFARIN, DIURETIC, STATIN, ANTIBIOTIC. (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 HAD RECURRENT (B)(4) BACTEREMIA. TRANSESOPHAGEAL ECHOCARDIOGRAPHY DONE SHOWED ECHODENSITY ON THE RIGHT VENTRICULAR LEAD AS IT TRANSVERSES THE RIGHT ATRIAL LEAD AND 2+ MR WITH A POST LEAFLET VALVE ECHODENSITY. THE SYSTEM WAS EXPLANTED 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
    59672 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO JUNCOS 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE TACHY LEAD