BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3051607 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04891
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5086MRI IMPLANTABLE PACING LEAD: (B)(6) 2011. (B)(4). LEAD REMAINS IN USE.

    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 RIGHT VENTRICULAR (RV) LEAD HAD A HIGH SENSING INTEGRITY COUNT (SIC). IT WAS ALSO REPORTED THAT THE ATRIAL LEAD WAS FAR FIELD R WAVE (FFRW) OVERSENSING AND AN IMPROPER MODE SWITCH OCCURRED. ADDITIONALLY, NOISE WAS SEEN ON THE ATRIAL LEAD DURING ISOMETRICS. THE SENSITIVITY WAS ADJUSTED TO STOP THE FFRW, THE MODE SWITCH WAS CORRECTED AND THE RV AND ATRIAL LEADS REMAIN 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 THERE WAS CONTINUED OVERSENSING ON THE RV LEAD WHICH WAS INTERMITTENTLY COINCIDING WITH P-WAVE AND T-WAVE. THEY COULD NOT REPRODUCE OVERSENSING WITH ARM MOVEMENTS OR ISOMETRICS AND THE LEAD IMPEDANCE AND THRESHOLDS ARE ACCEPTABLE. REPROGRAMMING WAS PERFORMED AND THE RV LEAD IS PLANNED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152150 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention RVDR01 IMPLANTABLE PULSE GENERATOR