BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE

    MDR report key: 3153622 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06139
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE PRIMARY ANALYSIS FINDING NOTED NO ANOMALIES WERE FOUND. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. THE HELIX OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. THE INSULATION OF THE LEAD WAS SEVERELY TWISTED DURING THE ATTEMPTED IMPLANT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE LEAD WAS RETURNED WITH THE HELIX STRETCHED. IT WAS ALSO OBSERVED THAT THE OUTER INSULATION HAD BEEN SEVERELY TWISTED DURING THE ATTEMPTED IMPLANT.

    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).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE RIGHT ATRIAL (RA) LEAD HAD UNACCEPTABLE MEASUREMENTS WITH LOW SENSING VALUES AND HIGH THRESHOLD. THE LEAD WAS DIFFICULT TO REMOVE. EVEN THOUGH IT WAS RETRACTED, THE LEAD REMAINED ATTACHED. IT TOOK MANY ATTEMPTS TO UNSCREW THE LEAD, AND ULTIMATELY, IT BECAME UNATTACHED. THE PHYSICIAN LOST CONFIDENCE IN THE LEAD AND REQUESTED A NEW ONE FOR IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258845 SELECTSECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR