BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 3002320 · Received March 13, 2013

    Report

    Report Number
    1028232-2013-00664
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 11, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. THE MANUFACTURING PROCESS FOR THIS DEVICE 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. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE LEAD DEMONSTRATED A DAMAGED INSULATION AT A DISTANCE OF ABOUT 27 CM DISTAL TO THE IS-1 CONNECTOR PIN. IN THAT SECTION, THE LEAD BODY WAS FOUND SQUEEZED AND DEFORMED. A SHORT CIRCUIT BETWEEN THE INNER AND OUT COIL OCCURRED. THESE FINDINGS CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE CLINICAL OBSERVATION AS 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 ANALYSIS REVEALED SIGNS OF WEAR IN THE PROXIMAL PART OF THE LEAD, AS A RESULT OF FRICTION BETWEEN THE LEAD BODY AND THE GENERATOR HOUSING. DAMAGES, SUCH AS CUTTINGS IN THE INSULATION AND PENETRATED BLOOD IN THE LUMEN OF THE LEAD, 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL DEVICE CHANGE OUT, THE LOCAL FIELD REPRESENTATIVE CALLED INTO BOSTON SCIENTIFIC TECHNICAL SERVICES TO DETERMINE IF A NEW LEAD WOULD BE NEEDED. MYOPOTENTIAL OVER-SENSING HAD BEEN OBSERVED ON THIS ATRIAL LEAD FOR "SOME TIME". THERE WERE NO ADVERSE PATIENT EFFECTS RESULTING FROM THE NOISE AND ALL MEASUREMENTS WERE FOUND TO BE STABLE. TS DISCUSSED THAT THE CAUSE MAY BE A SEAL PLUG ISSUE ON THE CHRONIC DEVICE. THE LEAD WAS TESTED ON A PACING SYSTEM ANALYZER AFTER BEING CONNECTED TO THE NEW DEVICE. THE PHYSICIAN ELECTED TO REPLACE THE LEAD DURING THE DEVICE CHANGE OUT EVEN THOUGH THE LEAD TESTED NORMAL. THE LEAD WAS EXPLANTED AND WILL BE RETURNED. THIS REPORT WILL BE UPDATE ONCE ANALYSIS HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104690 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization