BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 3153063 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01388
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    September 23, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT: 4968 IMPLANTABLE PACING LEAD (B)(6) 2010; ADDRL1 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED ON (B)(6) 2013. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE RIGHT ATRIAL (RA) LEAD HAD EXHIBITED HIGH IMPEDANCE AND NOISE AND WAS CONFIRMED TO BE FRACTURED. THE SURGEON ELECTED TO REPAIR THE LEAD DURING AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE ON (B)(6) 2013. THE LEAD WAS SUCCESSFULLY REPAIRED WITH MEDICAL ADHESIVE AND GORE AND IS NOW FUNCTIONING BIPOLAR. THE RA LEAD REMAINS IN SERVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. CORRECTION: THE INITIAL MEDWATCH REPORT WHICH WAS SUBMITTED ON (B)(6) 2013 SHOULD HAVE BEEN SUBMITTED AS A 30 DAY TIMELINE RATHER THAN BI-MONTHLY AS THIS EVENT INVOLVES A PEDIATRIC PATIENT. THE DUE DATE FOR THE INITIAL MEDWATCH REPORT SHOULD HAVE BEEN (B)(6) 2013 RATHER THAN (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FRACTURE OF THE ANODE CONDUCTOR IN 2011. A CHEST X-RAY CONFIRMED THE SEPARATION OF THE ELECTRODE. AT THE TIME, THE LEAD WAS REPROGRAMMED TO UNIPOLAR. SINCE, THE PATIENT HAD AN ATRIAL LEAD WARNING FOR LOW IMPEDANCE WITH TREND DATA INDICATING LOW IMPEDANCE MEASUREMENTS. IN CLINIC, THE ATRIAL IMPEDANCE WAS WITHIN NORMAL LIMITS. IT WAS ALSO NOTED THAT ATRIAL HIGH RATES HAD BEEN RECORDED WITH FAR FIELD OVERSENSING. THERE WERE NO FURTHER CHANGES MADE TO THE ATRIAL LEAD AND IT REMAINS IN USE. IT WAS FURTHER REPORTED THAT THEY PATIENT HAD PREVIOUSLY EXPERIENCED ABDOMINAL MUSCLE STIMULATION FROM THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256161 CAPSURE EPI ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R