BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 3871913 · Received June 13, 2014

    Report

    Report Number
    1028232-2014-01966
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 5, 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 WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION DEMONSTRATED A STRETCHED FIXATION HELIX. DAMAGING THE FIXATION HELIX REQUIRES THE PRESENCE OF MECHANICAL STRESS. PULLING FORCES DURING THE EXPLANT PROCEDURE SHOULD BE TAKEN INTO CONSIDERATION. DURING FURTHER ANALYSIS CUTTINGS IN THE INSULATION WERE FOUND WHICH OCCURRED MOST LIKELY DURING SURGERY. IN SUMMARY, A DEFORMED FIXATION HELIX WAS NOTED ON THE RETURNED LEAD. 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 ROUTINE EXPLANT PROCEDURE, THE PHYSICIAN WAS UNHAPPY WITH THE POSITION OF THIS LEAD. UPON REPOSITIONING THE LEAD, THE PHYSICIAN DETERMINED THE PATIENT WOULD BENEFIT MOST FROM A NEW LEAD. THIS LEAD WAS ULTIMATELY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350463 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization