BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3048936 · Received April 10, 2013

    Report

    Report Number
    9614453-2013-00779
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 24, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD 2011 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BECAME DIZZY AND LIGHTHEADED AND THEN FELL HITTING THEIR HEAD ON THE CONCRETE. IT WAS ALSO REPORTED THAT THE PATIENT WAS FOUND TO HAVE A SUBDURAL BLEED. INTERROGATION OF THE PATIENT'S DEVICE REVEALED TWO EPISODES OF VENTRICULAR FIBRILLATION (VF) THAT WERE BOTH ABORTED PRIOR TO THE DEVICE DELIVERING THERAPY, WITH ONE CORRELATING WITH THE SYNCOPAL EPISODE. THE PHYSICIAN FELT THAT THE SYNCOPAL EPISODE THAT LED TO THE PATIENT'S SUBDURAL HEMATOMA WAS DUE TO THE DELAY IN DELIVERING A SHOCK BY THE LONGER INITIAL DETECTION TIME. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS PART OF THE PAINFREE SMART SHOCK TECHNOLOGY CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154074 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R 6947 IMPLANTABLE DEFIB LEAD