BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART S DX 65/15

    MDR report key: 2565638 · Received May 4, 2012

    Report

    Report Number
    1028232-2012-01135
    Event Type
    Injury
    Date Received
    May 4, 2012
    Date of Event
    March 13, 2012
    Report Date
    April 16, 2012
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR ¿ THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS, THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MFR OF THIS PARTICULAR DEVICE. THE MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATION. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MFG.

    Description of Event or Problem · 1

    OUS MDR ¿ ELECTRICAL MEASUREMENTS AT IMPLANT WERE AS FOLLOWS: R=5, 6MV, PACING THRESHOLD = 0.7V AT 0.5 MS. DURING FOLLOW UP ON (B)(6) 2012, THE MEASUREMENT HAD CHANGED TO: R=2.4MV, PACING THRESHOLD = 2.4V AT 0.5 MS, SHOCK = 67 OHM, PACING = 456 OHM. THE PT IS NOT PM DEPENDENT. THE DOCTOR THOUGHT THE LEAD WAS DISLODGED. THERE WAS NO INDICATION GIVEN OF ANY SORT OF INTERVENTION PERFORMED. ALL AVAILABLE INFO SUGGESTS THAT THIS DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART S DX 65/15 ICD LEAD LWS BIOTRONIK, INC. 365500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other