BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 3232158 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01943
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE AS WELL AS ON THE RETURNED DEVICE DATA. THE MANUFACTURING PROCESS FOR THIS ICD WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. THE RETURNED DEVICE DATA HAVE BEEN ANALYSED. THE INSPECTION REVEALED THE PRESENCE OF NOISE IN THE VENTRICULAR AND FAR-FIELD CHANNELS, CONFIRMING THE CLINICAL OBSERVATION. THE DETECTION OF NOISE IN THE VENTRICULAR CHANNEL LED TO A SHOCK DELIVERY, AS MENTIONED IN THE COMPLAINT DESCRIPTION. UPON RECEIPT, THE LEAD WAS FOUND DISSECTED IN TWO FRAGMENTS. A PIECE OF LEAD BODY BETWEEN THE TWO FRAGMENTS AND ANOTHER PIECE AT THE MOST DISTAL PART OF THE LEAD WERE NOT RETURNED FOR ANALYSIS. A TOTAL OF ABOUT 3.5 CM OF LEAD BODY WERE NOT AVAILABLE FOR ANALYSIS. IT IS REASONABLE TO ASSUME THAT THE FRAGMENTATION OF THE LEAD ORIGINATED FROM THE EXPLANTATION PROCEDURE. THE RETURNED FRAGMENTS WERE VISUALLY AND ELECTRICALLY ANALYSED. THE INSPECTION DID NOT SHOW ANY PECULIARITY WHICH MIGHT HAVE LED TO THE CLINICAL OBSERVATION. AT A NEXT STEP, THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS LEAD WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. THE RECEIVED X-RAY IMAGES WERE INSPECTED. THE IMAGE CORRESPONDING TO THE STATUS OF THE SYSTEM A FEW DAYS AFTER IMPLANT REVEALED A NORMAL SLACK OF THE LEAD. THE IMAGE SHOWING THE STATUS OF THE SYSTEM PREVIOUS TO THE EXPLANTATION PROCEDURE REVEALED THAT THE ICD ROTATED OVER TWO AXES SINCE THE DATE OF IMPLANT AND THE LEAD SLACK INCREASED NOTABLY, WHICH REPRESENTS A RISK OF LEAD FRACTURE. IN SUMMARY, THE ICD WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING. THE ANALYSIS OF THE RETURNED DEVICE DATA CORROBORATED THE CLINICAL OBSERVATION. THE RETURNED LEAD FRAGMENTS DID NOT SHOW ANY INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM. BASED ON THE INFORMATION AVAILABLE FOR ANALYSIS, NO CONCLUSIONS CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANT DURATION OF ABOUT 25 MONTHS AN INAPPROPRIATE SHOCK WAS REPORTED. LEAD FRACTURE WAS SUSPECTED. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332533 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization