BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/16

    MDR report key: 1780881 · Received July 29, 2010

    Report

    Report Number
    1028232-2010-01700
    Event Type
    Injury
    Date Received
    July 29, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 13, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    PER (B) (4) ADVERSE EVENT REPORT, DURING THRESHOLD TESTING AT A FOLLOW-UP VISIT, BOTH THE RV AND LV LEADS SHOWED SIGNS OF DIAPHRAGMATIC STIMULATION. A CHEST X-RAY WAS PERFORMED AND AT A SUBSEQUENT FOLLOW-UP, THE PHYSICIAN EXPRESSED CONCERNS ABOUT PERFORATION. THERE WAS NO EVIDENCE OF A PERICARDIAL EFFUSION. SINCE THIS PATIENT WAS REPORTED TO HAVE AN INFECTION OF THE ICD POCKET, THE PHYSICIAN ELECTED TO REMOVE THESE LEADS AND THE REST OF THE SYSTEM FROM SERVICE. THE SYSTEM HAS BEEN RETAINED BY THE HOSPITAL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED. SYSTEM REMOVED FOR INFECTION: LUMAX 540 HF-T, (B) (4), MDR 1028232-2010-01697, SETROX S 53, (B) (4), MDR 1028232-2010-01698, COROX OTW-S 85-BP, (B) (4), MDR 1028232-2010-01701.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization