BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART TD 65/18

    MDR report key: 3232159 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01945
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    April 18, 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 RETURNED LEAD WAS ONLY AVAILABLE IN FRAGMENTS. THE DISTAL FRAGMENT, INCLUDING THE TIP ELECTRODE, WAS NOT AVAILABLE FOR ANALYSIS. THE LEAD HAD BEEN CUT THROUGH 11 CM DISTAL OF THE IS-1 CONNECTOR PIN, PROBABLY WITH A SCALPEL. DURING THE ANALYSIS OF THE FRAGMENT, ABRASION TRACES WERE NOTED AT THE IS-1 AND THE DF-1 CONNECTIONS. THESE CHARACTERISTIC ABRASION TRACES INDICATE AN INTERACTION OF THE CONNECTOR EXITS WITH EACH OTHER. FURTHERMORE, THE ANALYSIS SHOWED, AS MENTIONED IN THE CLINICAL COMPLAINT, THAT THE DF-1 CONNECTOR EXIT WAS TORN OFF. THIS DAMAGE CAN PROBABILITY BE REGARDED AS THE CAUSE FOR THE MEASURED SHOCK IMPEDANCE OF MORE THAN 150 OHM. THE ANALYSIS OF THE X-RAY IMAGES SHOWED AN EXTRA POCKET FOR THE EXCESSIVE LEAD CONDUCTOR SUPERIOR TO THE GENERATOR. IN THE REGION OF THIS EXTRA POCKET, SEVERE BENDING RADII OF THE LEAD WERE NOTICEABLE AT THE CONNECTOR EXITS. EXCESSIVE MECHANICAL STRESS IN JUST THIS ARE COULD HAVE CONTRIBUTED TO THE CLINICAL COMPLAINT. THE MEASUREMENT OF THE DIRECT-CURRENT RESISTANCES OF THE ELECTRICAL CONDUCTORS DID NOT SHOW ANYTHING ABNORMAL. IN SUMMARY, THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT, AFTER AN IMPLANTATION TIME OF 18 MONTHS, AN INCREASE IN THE SHOCK IMPEDANCE (>150 OHM) WAS DETECTED. THE LEAD WAS EXPLANTED IN FRAGMENTS. A LEAD FRACTURE WAS OBSERVED IN THE PROCESS. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331547 LINOX SMART TD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 359074

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization