BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 4601406 · Received March 13, 2015

    Report

    Report Number
    1028232-2015-00787
    Event Type
    Malfunction
    Date Received
    March 13, 2015
    Date of Event
    February 6, 2015
    Report Date
    February 27, 2015
    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS UPGRADED FROM A SINGLE CHAMBER DEVICE TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR. AT THE IMPLANT PROCEDURE, THE RIGHT ATRIAL LEAD MEASUREMENTS WERE 4.0 MV P-WAVES AND 1.8V AT 0.5MS CAPTURE THRESHOLDS. THE FOLLOWING DAY, THE P-WAVES MEASURED 1.4 MV AND THERE WAS QUESTIONABLE CAPTURE ON THE RA LEAD. THE PATIENT'S UNDERLYING RHYTHM AT THE PROCEDURE WAS SINUS BRADYCARDIA AT 45 TO 50 BPM WITH PREMATURE VENTRICULAR CONTRACTIONS, AND PREMATURE ATRIAL CONTRACTIONS WERE NOTED ON THE NEXT DAY EVALUATION. STRIPS WERE SENT IN FOR BOSTON SCIENTIFIC TECHNICAL SERVICES TO REVIEW AND VARIABLE CAPTURE IN THE ATRIUM WAS NOTED BELOW 4V. X-RAYS WERE PENDING. ADDITIONAL INFORMATION WAS RECEIVED THAT ATRIAL LEAD WAS CONFIRMED TO BE DISLODGED BY X-RAY, AND A LEAD REVISION PROCEDURE WAS PERFORMED LATER THE SAME DAY. THERE WERE NO ISSUES FOLLOWING THE REVISION. THE PATIENT STAYED AN EXTRA NIGHT AT THE HOSPITAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS UPGRADED FROM A SINGLE CHAMBER DEVICE TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR. AT THE IMPLANT PROCEDURE, THE RIGHT ATRIAL LEAD MEASUREMENTS WERE 4.0 MV P-WAVES AND 1.8V AT 0.5MS CAPTURE THRESHOLDS. THE FOLLOWING DAY, THE P-WAVES MEASURED 1.4 MV AND THERE WAS QUESTIONABLE CAPTURE ON THE RA LEAD. THE PATIENT'S UNDERLYING RHYTHM AT THE PROCEDURE WAS SINUS BRADYCARDIA AT 45 TO 50 BPM WITH PREMATURE VENTRICULAR CONTRACTIONS, AND PREMATURE ATRIAL CONTRACTIONS WERE NOTED ON THE NEXT DAY EVALUATION. STRIPS WERE SENT IN FOR BOSTON SCIENTIFIC TECHNICAL SERVICES TO REVIEW AND VARIABLE CAPTURE IN THE ATRIUM WAS NOTED BELOW 4V. X-RAYS WERE PENDING. ADDITIONAL INFORMATION WAS RECEIVED THAT ATRIAL LEAD WAS CONFIRMED TO BE DISLODGED BY X-RAY, AND A LEAD REVISION PROCEDURE WAS PERFORMED LATER THE SAME DAY. THERE WERE NO ISSUES FOLLOWING THE REVISION. THE PATIENT STAYED AN EXTRA NIGHT AT THE HOSPITAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, 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
    173710 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization