BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3860261 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05521
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 10, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD.

    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 MEDICAL PRODUCTS: A 5086MRI52 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO EMERGENCY ROOM (ER) 3 DAYS AFTER IMPLANT WITH CHEST PAIN AND WAS SENT HOME. THE PATIENT CAME BACK TO ER THE NEXT DAY ON SUNDAY WITH CHEST PAIN AND HYPOTENSION. AN ECHOCARDIOGRAM SHOWED A PERICARDIAL EFFUSION. WHILE IN THE ER, THE PATIENT BECAME UNRESPONSIVE AND REQUIRED INTUBATION. THE PATIENT WAS TAKEN TO SURGERY WHERE A PERICARDIAL DRAIN WAS PLACED. THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS AND HAD POSSIBLY PERFORATED THE HEART AND DISLODGED OUTSIDE OF THE HEART CAUSING TAMPONADE. THE RV LEAD WAS REPOSITIONED AND REMAINS IN USE. THE RIGHT ATRIAL (RA) LEAD ALSO HAD AN APPARENT DISLODGEMENT. THE PHYSICIAN WAS UNSUCCESSFUL AT REPOSITIONING THE RA LEAD AND WAS UNABLE TO ACHIEVE ADEQUATE PACING THRESHOLDS AND SENSING VALUES. THE LEAD WAS REMOVED AND REPLACED. THE PATIENT REQUIRED INTUBATION AND SURGICAL PLACEMENT OF PERICARDIAL DRAIN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343267 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| L| R A2DR01 IPG