BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 65/16

    MDR report key: 3092021 · Received May 3, 2013

    Report

    Report Number
    1028232-2013-01210
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 3, 2013
    Report Date
    April 22, 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

    UPON RECEIPT, THE LEAD WAS FOUND DISSECTED ABOUT 14 CM DISTAL TO THE IS-1 CONNECTOR PIN. BOTH FRAGMENTS WERE RETURNED FOR ANALYSIS. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED DURING SURGERY. THE LEAD FRAGMENTS WERE EXTENSIVELY ANALYSED. THE ANALYSIS DEMONSTRATED INSULATION DAMAGES AND A FRACTURED CONDUCTOR CABLE TO THE RV SHOCK COIL AT SOME 27 CM DISTAL TO THE IS-1 CONNECTOR PIN. IN THAT SECTION, THE LEAD BODY WAS FOUND SQUEEZED AND DEFORMED. THE FRACTURE OF THE CONDUCTOR CABLE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED OUT OF RANGE SHOCK IMPEDANCE MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF CLAVICULAR - FIRST RIB ENTRAPMENT. FURTHER DAMAGES OCCURRED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANT DURATION OF 10 MONTHS IT WAS REPORTED THAT THE SHOCK IMPEDANCE WAS OUT OF RANGE. PATIENT COMPLAINED ABOUT MOVEMENTS OF ICD IN THE POCKET. NO OTHER ADVERSE PATIENT SIDE EFFECTS WERE REPORTED. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194137 LINOX SMART SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 359066

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization