BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 3932235 · Received July 14, 2014

    Report

    Report Number
    1028232-2014-002379
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 19, 2014
    Report Date
    July 2, 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 SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. DURING THE VISUAL INSPECTION, A BEND IN THE DISTAL PART OF THE LEAD WAS NOTED, WHICH CAN BE CONSIDERED TO BE THE ROOT CAUSE OF THE CLINICAL OBSERVATION. BENDING THE LEAD BODY REQUIRES THE PRESENCE OF MECHANICAL STRESS. BASED ON THE DAMAGE SYMPTOMS, IT IS REASONABLE TO ASSUME THAT THIS DAMAGE WAS DUE TO TENSILE FORCES, APPLIED DURING THE SURGERY. FURTHER INSPECTION OF THE LEAD DEMONSTRATED CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE OUTER COIL WHICH OCCURRED MOST LIKELY DURING THE EXPLANT PROCEDURE. BLOOD PENETRATED THE LEAD IN THE CUT AREAS. IN SUMMARY, THE LEAD'S DISTAL PART WAS FOUND BENT, WHICH RESULTED MOST LIKELY FROM THE SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Additional Manufacturer Narrative · 1

    WE RECEIVED YOUR EVENT DESCRIPTION FOR THE ABOVE MENTIONED DEVICE AND WOULD LIKE TO THANK YOU FOR SUPPORTING OUR POST-MARKET SURVEILLANCE. AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES. SHOULD ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED NON DETECTION DUE TO DISLODGEMENT. AN ATTEMPT WAS MADE TO REPOSITION THE LEAD BUT THE HELIX COULD NOT RETRACT OR EXTEND. A NEW RV LEAD WAS IMPLANTED WITHOUT ISSUE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410395 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization