BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4831643 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05439
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 13, 2015
    Report Date
    April 13, 2015
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 ANALYSIS OF THE DEVICE MEMORY INDICATED UNDERSENSING/NO RV (RIGHT VENTRICULAR) SENSING. IT WAS NOTED THE DAILY LEAD TREND DATA SHOWED THE R-WAVE AMPLITUDE WAS 9.5MV OR GREATER THROUGH 2015 (B)(6)AND HAD DECREASED TO 1.25MV ON 2015 (B)(6).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (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 WAS TAKEN TO HOSPITAL DUE TO ACUTE MYOCARDIAL INFARCTION (AMI). AFTER THE PATIENT PRESENTED, A STENT WAS POSITIONED AND A DEVICE INTERROGATION CONFIRMED AN RIGHT ATRIAL (RA) LEAD SENSING AND PACING FAILURE, ALONG WITH A RIGHT VENTRICULAR (RV) LEAD SENSING FAILURE. THE DEVICE WAS REPROGRAMMED TO DDD MODE AND IT WAS NOTED THAT PRIOR TO THE PATIENT EXPERIENCING THE AMI, THE LEAD TREND SHOWED R-WAVE AND P-WAVE SENSING HAD BECOME "EXTREMELY LOW," ALONG WITH A SLIGHT DECREASE IN RV IMPEDANCE MEASUREMENTS. IT WAS ALSO NOTED THAT THE ELECTROGRAM (EGM) CONFIRMED THERE WAS ALWAYS NOISE IN THE RV TIP-RING CHANNEL THAT REMAINED BELOW SENSING THRESHOLD AND A X-RAY SHOWED THAT THE PACEMAKER WAS ROTATED BY APPROXIMATELY 60 DEGREES, THE ATRIAL LEAD APPEARED TO BE PULLED, AND "THE SITE AROUND THE SLEEVE WAS PRESSED SEEMINGLY." THE PATIENT WAS CONTINUOUSLY MONITORED AND A SECOND DEVICE INTERROGATION DISPLAYED RA UNDERSENSING, ALONG WITH NO RV SENSING OF THE R-WAVE; AS A RESULT, THE ATRIAL OUTPUT WAS THEN INCREASED AND IT WAS NOTED THE PATIENT'S BLOOD PRESSURE IMPROVED. THE PATIENT WAS THEN IMPLANTED WITH AN INFLATION INTRA-AORTIC BALLOON PUMP (IABP) AND AN ANGIOGRAPHY OF THE LEFT VENTRICLE WAS PERFORMED. THE PHYSICIANS NOTED A SUSPECTED VENTRICULAR SEPTUM PERFORATION AND THE DEVICE WAS THEN REPROGRAMMED TO ATRIAL PREFERENCE PACING, WHICH IMPROVED THE PATIENT'S BLOOD PRESSURE AND THE P-WAVE INCREASED TO A NORMAL RANGE. A WEEK LATER THE PATIENT UNDERWENT OPEN CHEST SURGERY TO PATCH THE PERFORATION SITE THAT RESULTED FROM THE AMI AND A CORONARY BYPASS SURGERY WAS ALSO PERFORMED. THE RA AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377818 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 00077 YR Hospitalization| R 4574-45 LEAD, A3DR01 DEVICE