BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 3863097 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01312
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    August 31, 2012
    Report Date
    July 16, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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. PRODUCTS: 429688 LEAD IMPLANTED: (B)(6) 2012; 407652 LEAD IMPLANTED: (B)(6) 2012. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A FEW MONTHS OF IMPLANT, THE PATIENT EXPERIENCED HEMATOMA IN THE POCKET AREA, WITH SYMPTOMS OF SEROUS SE CREATION. SUBFEBRILE TEMPERATURE AND POCKET INFECTION WERE ALSO NOTED. THE PATIENT WAS THERAPEUTICALLY PROVIDED POCKET REVISION, ANTIBIOTICS, ANTISEPTIC LAVAGE, AND THE SUTURES WERE REMOVED. THE PATIENT WAS ALSO HOSPITALIZED MULTIPLE TIMES. EVENTUALLY THE DEVICE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WAS NOTED TO BE PART OF THE OPTILINK HF STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339427 PROTECTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D364TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 6944 LEAD