BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2953614 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00244
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 30, 2012
    Report Date
    November 6, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 U.S., HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. CONCOMITANT MEDICAL DEVICES: UNKNOWN COMPETITOR IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2012; (B)(4) IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2012. (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 ONE DAY AFTER IMPLANT, ABNORMAL BLOOD TESTS REVEALS THAT THE PATIENT DEVELOPED SEPSIS STAPHYLOCOCCUS ALONG WITH A FEVER. THE PATIENT HAD A PROLONGED HOSPITAL STAY FOR TREATMENT WITH MEDICATION. THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56359 PROTECTA XT CRT-D LWS IPG MFG SWITZERLAND D354TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD