BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3863089 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01314
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 30, 2013
    Report Date
    July 2, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: 407652 LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO MONTHS AFTER IMPLANT, THE PATIENT HAD A PURULENT INCISION WOUND WITH POCKET INFECTION. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) NOTED AN ¿ARM FLOATING STRUCTURE¿ IN THE RIGHT VENTRICLE. IT WAS ALSO REPORTED THAT THE PATIENT HAD A FISTULA IN THE AREA OF THE THORACOTOMY. THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND LEADS WERE REMOVED AND PATIENT PLACED ON ANTIBIOTICS. THE PATIENT IS ENROLLED IN THE OPTILINK HF CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339813 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D354TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R 693565 LEAD