BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART PROMRI S 65

    MDR report key: 2860126 · Received November 29, 2012

    Report

    Report Number
    1028232-2012-02946
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LEAD WAS THOROUGHLY TESTED. DURING THE ANALYSIS, IT WAS NOTED THAT THE TIP ELECTRODE HAD BEEN PULLED OUT OF THE ADHESIVE CONNECTION OF THE RING ELECTRODE. IN ADDITION, THE STEROID COLLAR WAS DAMAGED IN SEVERAL PLACES. THESE DAMAGES INDICATE A SIGNIFICANT MECHANICAL FORCE IMPACT. THE MECHANICAL STRESS DURING THE EXPLANTATION SHOULD BE CONSIDERED AS CAUSE. THERE WERE NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - PERFORATION OF THE RIGHT MYOCARDIUM WAS REPORTED. THE DATE OF THIS EVENT WAS NOT PROVIDED. THIS LEAD WAS NOT IMPLANTED AND WAS RETURNED FOR ANALYSIS. THERE WERE NO OTHER ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART PROMRI S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 377166

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization