BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3071681 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05236
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    January 22, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4) IMPLANTABLE PULSE GENERATOR (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE. A 65 LOW IMPEDANCE PACES WERE OBSERVED PRIOR TO THE LEAD WARNING ON (B)(6) 2013. A 90 NON-PHYSIOLOGIC SENSES WERE OBSERVED PRIOR TO THE LEAD WARNING ON (B)(6) 2013 AND 197 HAD BEEN OBSERVED POST LEAD WARNING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING OVERSENSING, NOISE AND LOW IMPEDANCE DUE TO A POSSIBLE FRACTURE. IT WAS FURTHER REPORTED THAT AN INSULATION BREACH WAS VISUALLY CONFIRMED. THE LEAD WAS REPROGRAMMED UNTIL A REVISION COULD BE COMPLETED. THE PATIENT IS A PARTICIPANT IN THE SYSTEMS LONGEVITY CLINICAL STUDY. IT WAS LATER REPORTED THAT THE RV LEAD WAS EXTRACTED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING OVERSENSING, NOISE AND LOW IMPEDANCE DUE TO A POSSIBLE FRACTURE. IT WAS FURTHER REPORTED THAT AN INSULATION BREACH WAS VISUALLY CONFIRMED. THE LEAD WAS REPROGRAMMED UNTIL A REVISION COULD BE COMPLETED. THE PATIENT IS A PARTICIPANT IN THE SYSTEMS LONGEVITY CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE RV LEAD HAD EXHIBITED AN INCREASE IN THRESHOLDS PRIOR TO REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171806 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407458

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R 4574 IMPLANTABLE PACING LEAD