BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4314424 · Received December 10, 2014

    Report

    Report Number
    2649622-2014-15279
    Event Type
    Injury
    Date Received
    December 10, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    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 THIS DATA INDICATED OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD. IT WAS NOTED THAT THERE WERE 505 V-SIC (VENTRICULAR- SHORT INTERVAL COUNTS) THAT OCCURRED SINCE 2014-(B)(6) AND NINE NSVT (NON-SUSTAINED VENTRICULAR TACHYCARDIA) EPISODES OF LESS THAN 220 MN V-V CYCLE WERE RECORDED ON FIVE DAYS DURING (B)(6) 2014.

    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. IT WAS FURTHER REPORTED THAT ANALYSIS OF THIS DATA INDICATED THAT THERE OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER) ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WERE 10 NST (NON-SUSTAINED TACHYCARDIA) EPISODES WITH V-V INTERVALS LESS THAN 220 MS FROM (B)(4) 2015. ADDITIONALLY, THERE WAS 4017 V-SICS SINCE LAST SESSION 189 DAYS AGO. IT WAS NOTED PACING INHIBITED DUE TO OVERSENSING.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: A2DR01 IPG IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD OVERSENSING AS IT SHOWED TO HAVE FIVE HUNDRED AND TWO SHORT V-V¿S. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD CONTINUED TO EXHIBIT OVERSENSING V-SIC (VENTRICULAR - SENSING INTEGRITY COUNTER) IS GREATER THAN FOUR THOUSAND. ADDITIONALLY, IT WAS NOTED THAT THE EPISODES WITH EGM (ELECTROGRAM) AVAILABLE APPEAR TO BE OVERSENSING WHICH SHOW INHIBITION OF PACING. THEY WERE UNABLE TO REPRODUCE OVERSENSING WITH ISOMETRICS OR POCKET MANIPULATION. THE SENSITIVITY WAS PROGRAMMED AND THE LEAD WAS ALSO REPROGRAMMED TO UNIPOLAR. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798090 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R