BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3991227 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08240
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD WAS EXTRINSICALLY OVER-ROTATED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE LEAD WAS RECEIVED WITH THE HELIX FULLY EXTENDED, AND DISTORTION OF THE DISTAL CONDUCTOR WITHIN THE IS-1 CONNECTOR. THIS IS INDICATIVE OF THE CONNECTOR PIN BEING TURNED AN EXCESSIVE NUMBER OF TIMES DURING HELIX EXTENSION.

    Additional Manufacturer Narrative · 1

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

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD HELIX WOULD NOT RETRACT. THE LEAD WAS ATTEMPTED AND NOT USED. ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472567 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