BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT SECURE

    MDR report key: 1981091 · Received February 8, 2011

    Report

    Report Number
    2649622-2011-00196
    Event Type
    Injury
    Date Received
    February 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND; THE FULL LEAD WAS RETURNED FOR ANALYSIS. BLOOD/BODY FLUID WAS OBSERVED ON THE PROXIMAL CONDUCTOR AND THE HELIX MECHANISM (NOT OBSTRUCTED). THE OUTER INSULATION WAS MELTED, HAD ENVIRONMENTAL STRESS CRACKING AND COSMETIC DEPRESSIONS. APPARENT EXPLANT DAMAGE WAS OBSERVED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOT ENOUGH SLACK IN THE LEAD TO ALLOW FOR THE PATIENTS GROWN SO THE VOLTAGE THRESHOLD INCREASED. THE 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
    1 SELECT SECURE IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 3830 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PULSE GENERATOR| 3830 IMPLANTABLE PACING LEAD| 3830 IMPLANTABLE PACING LEAD