BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 4833927 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06868
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 3, 2015
    Report Date
    June 29, 2020
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY MELTED BUT NOT BREACHED. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. NO ANOMALIES WERE FOUND ON THE SAVE TO DISK.

    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: D314DRG ICD, IMPLANTED: (B)(6) 2012. (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'S RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS, HIGH IMPEDANCE, HIGH SHORT INTERVAL COUNTS (SIC), OVERSENSING AND NOISE. ADDITIONALLY, THE RV LEAD HAD A SUSPECTED FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED. FURTHERMORE, DURING THE PROCEDURE THE RIGHT ATRIAL (RA) LEAD BECAME LOOSE. THE RA LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379681 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R 694958 LEAD| 694958 LEAD