BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2951859 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00067
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 24, 2012
    Report Date
    November 6, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS IN THE SAME BRAND FAMILY AS A DEVICE MARKETED IN THE U.S. CONCOMITANT PRODUCT: 6947M IMPLANTABLE DEFIB LEAD: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN IN THEIR LEFT ARM AND RECURRENCE OF THE POCKET HEMATOMA HAD OCCURRED. A WICK WAS PLACED IN A SORE OF THE INCISION MADE AT SYSTEM IMPLANT. DEVICE REMAINS IMPLANTED AND IN USE. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST SYSTEM IMPLANT, IT WAS DISCOVERED THAT THE PATIENT HAD A HEMATOMA. THE PATIENT WAS TREATED FOR THE HEMATOMA THROUGH INTUBATION AND MEDICATION. THE DEVICE, RIGHT VENTRICULAR (RV) AND ATRIAL LEAD REMAIN IN USE. THE PATIENT WAS ENROLLED IN THE (B)(4) 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
    55737 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R 3830 IMPLANTABLE PACING LEAD