BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2954505 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00478
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58604 PROTECTA XT CRT-D LWS IPG MFG SWITZERLAND D354TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R 6947M DEFIB LEAD, 4574 PACING LEAD, 4296 LEAD