BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINOX TD 65/16

    MDR report key: 4942764 · Received July 27, 2015

    Report

    Report Number
    1028232-2015-02600
    Event Type
    Death
    Date Received
    July 27, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 15, 2015
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD AND FRAGMENTS OF THE LEAD WERE RETURNED FOR ANALYSIS. AN ADDITIONAL PACE/SENSE LEAD (MEDTRONIC (B)(4)) HAD ALREADY BEEN IMPLANTED NO LATER THAN (B)(6) 2013. THIS SUGGESTS IRREGULARITIES OF THE LEAD ALREADY BEFORE THIS DATE. NO FOLLOW-UPS HAD BEEN PERFORMED SINCE (B)(6) 2013. THE DEVICE MEMORY DATA OF THE ICD WERE ANALYZED. AN INCREASE IN THE SHOCK IMPEDANCE TO >150 OHM SINCE (B)(6) 2014 WAS REGISTERED, AS WELL AS AN INCREASE OF THE PACING IMPEDANCE FROM >700 OHM TO >1900 OHM BETWEEN (B)(6) 2015.ON (B)(6) 2015, VENTRICULAR FIBRILLATION WAS DETECTED BY THE ICD BASED ON ALREADY WEAKLY DEVELOPED INTRINSIC SIGNALS, WHICH LED TO SEVERAL SHOCK DELIVERIES. HOWEVER, THEY DID NOT TERMINATE THE VENTRICULAR FIBRILLATION.THE INCREASE IN THE SHOCK IMPEDANCE TO >150 OHM AND THE INEFFECTIVE SHOCK DELIVERIES SUGGEST DAMAGE TO THE LEAD, WHICH WAS CONFIRMED DURING THE LEAD ANALYSIS.THE WEAK INTRINSIC SIGNALS AND THE INCREASE IN THE PACING IMPEDANCE LEAD TO THE ASSUMPTION THAT (B)(6) 2015 WAS THE TIME OF DEATH.DURING THE COMPLETE FUNCTION TEST, THE ICD PROVED TO BE FREE OF DEFECTS, AND A DEVICE MALFUNCTION OF THE ICD CAN THEREFORE BE RULED OUT.ONLY THE DF-1 CONNECTOR EXITS HV-1 AND HV-2 AND A LEAD FIXATION SHEATH WERE RETURNED FOR ANALYSIS. THE IS-1 CONNECTOR EXIT AND THE SHUNT AND THE DISTAL PART OF THE LEAD BODY WERE NOT AVAILABLE FOR ANALYSIS. THE LEAD HAD BEEN CUT THROUGH 8 CM DISTAL OF THE DF-1 CONNECTOR PIN, PROBABLY WITH A SCALPEL.THE ANALYSIS FOUND MULTIPLE INSTANCES OF DAMAGE ON BOTH DF-1 CONNECTOR EXITS. THE FACT THAT BOTH CONNECTOR EXITS WERE EQUALLY DAMAGED AND TORN OFF INDICATES A LONG-LASTING IMPACT OF STRONG MECHANICAL TENSILE FORCES ALREADY DURING THE IMPLANTATION TIME.THE TYPE OF THESE DAMAGES IS CHARACTERISTIC FOR A STRONGLY BENT POSITION OF THE CONNECTOR EXIT AFTER EXITING THE ICD CONNECTOR SYSTEM WITH SIMULTANEOUS OCCURRENCE OF STRONG PRESSURE OF THE LEAD ONTO THE ICD HOUSING.X-RAY IMAGES OR DIAGNOSTIC IMAGES OF ANY OTHER KIND, WHICH COULD PROVIDE INFORMATION ON THE POSITIONAL RELATIONSHIPS OF THE IMPLANTED SYSTEM IN THE BODY, WERE NOT AVAILABLE FOR ANALYSIS.CONCLUSIONTHE ANALYSIS OF THE ICD INDICATES (B)(6) 2015 AS THE TIME OF DEATH. ON THE SAME DAY, PERSISTENT VENTRICULAR FIBRILLATION HAD BEEN RECORDED, WHICH WAS PROPERLY DETECTED BY THE ICD. THE FOLLOWING SHOCK DELIVERIES OF THE ICD DID NOT TERMINATE THE VENTRICULAR FIBRILLATION. THE REASON FOR THIS IS UNKNOWN. BASED ON THE DEVICE DATA AND THE DAMAGE TO THE LEAD FRAGMENTS, IT IS POSSIBLE THAT THE SHOCK ENERGY DID NOT COMPLETELY REACH THE HEART MUSCLE.THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS FOR EITHER THE LEAD OR THE ICD.

    Description of Event or Problem · 1

    (B)(6) MDR - THIS DEVICE WAS EXPLANTED BY A FORENSIC MEDICAL PERSON AND RELEASED BY THE INVESTIGATING PROSECUTOR. THE DEVICE WAS RETURNED FOR ANALYSIS. THE DATES OF IMPLANT AND EXPLANT WERE NOT PROVIDED. THIS IS ALL OF THE INFORMATION THAT WAS PROVIDED TO US AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486018 LINOX TD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 351337

    Patients

    Seq Age Sex Outcome Treatment
    1 Death