BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 4231927 · Received November 6, 2014

    Report

    Report Number
    1028232-2014-003996
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    March 22, 2013
    Report Date
    October 27, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS FOUND DISSECTED. TWO FRAGMENTS WERE RECEIVED FOR ANALYSIS. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED IN THE COURSE OF THE EXPLANTATION PROCEDURE. THE RETURNED FRAGMENTS WERE VISUALLY AND ELECTRICALLY ANALYZED. THE INSPECTION REVEALED SEVERAL EXPLANTATION DAMAGES SUCH AS CUTTINGS IN THE INSULATION AND A DAMAGED SILICONE SEALING OF THE IS-1 CONNECTOR PIN WERE DETECTED. THE FIXATION HELIX WAS FOUND DEFORMED. IN ADDITION, THE DC RESISTANCES OF THE CONDUCTOR FRAGMENTS WERE INVESTIGATED. NO PECULIARITIES WERE FOUND. THE ANALYSIS OF THE AVAILABLE LEAD FRAGMENTS DID NOT REVEAL ANY INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD IMPEDANCE MEASUREMENT HAS INCREASED FROM 500 OHMS TO 1100 OHMS SINCE LAST DEVICE INTERROGATION OVER SIX MONTHS EARLIER. IT WAS NOTED THAT THRESHOLD MEASUREMENT HAS ALSO INCREASED FROM 1.6 VOLTS AT 0.5 MS TO 3 VOLTS AT 1 MS. THERE WAS NO NOISE ON THE LEAD. THE PHYSICIAN MAY CONSIDER REPROGRAMMING THE DEVICE TO A SINGLE CHAMBER MODE BECAUSE THE PATIENT HAS NO BRADYCARDIA INDICATIONS. HOWEVER, AT THIS TIME THE PHYSICIAN HAS OPTED TO MONITOR THE PATIENT AS THE PATIENT DOES NOT PACE MUCH IN THE ATRIUM AND THE DEVICE IS STILL SENSING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714993 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Other