BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3865012 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07485
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    NVN
    PMA / PMN Number
    P930039
    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 RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: EXPLANTED: 2014 (B)(6); PRODUCT ID 407658 ATRIAL LEAD IMPLANTED: 2014 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT ID 407658 ATRIAL LEAD IMPLANTED: 2014 (B)(6), EXPLANTED: 2014 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD WAS CAPPED DUE TO NO CAPTURE, HIGH/UNSTABLE THRESHOLDS, AND LOW PACING IMPEDANCE. THE VENTRICULAR LEAD REMAINS IN THE PATIENT. DURING THE IMPLANT PROCEDURE TO REPLACE THE GENERATOR DUE TO NORMAL BATTERY DEPLETION, THE PHYSICIAN ATTEMPTED, BUT COULD NOT USE TWO ATRIAL LEADS DUE TO HELIX ISSUES. IN EACH CASE, THE HELIX WOULD EXTEND DURING PLACEMENT BUT WOULD NOT RETRACT. THE ATRIAL LEADS WERE REPLACED AND RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339221 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Hospitalization| R T60A1B IPG