BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 HF-T

    MDR report key: 3120197 · Received May 20, 2013

    Report

    Report Number
    1028232-2013-01379
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    March 28, 2012
    Report Date
    May 6, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE PATIENT WAS EXPERIENCING SOME INTERMITTENT DISCOMFORT IN HER LEFT ANTECUBITAL FOSSA AREA FOLLOWING IMPLANT OF THIS ICD. PATIENT REPORTS EXPERIENCING SOME LEFT SHOULDER AND LEFT ARM INTERMITTENT DISCOMFORT. THE PAIN IS GENERALLY LOCALIZED TO THE ANTECUBITAL FOSSA AREA, BUT THERE IS SOME INTERMITTENT TINGLING AND DISCOMFORT WHICH RADIATES DOWN TO HER LEFT WRIST AREA. SHE REPORTS INTERMITTENT CYANOSIS IN HER DIGITS. SHE REPORTS SOME TENDERNESS AROUND HER PECTORAL INCISIONAL AREA. SHE DENIES ANY FEVERS, CHILLS, OR OTHER CONSTITUTIONAL SYMPTOMS. PHYSICAL INSPECTION REVEALED THE SITE TO BE WELL APPROXIMATED WITH STERI-STRIPS. TEMPERATURE IS WARM AND DRY, AND IS MEASURED AT 98.6 "TYMPANICALLY". THERE IS AN EXAGGERATED RESPONSE TO SITE PALPATION. THERE IS NO SIGNIFICANT EDEMA IN HER PECTORAL, LEFT UPPER AND LEFT LOWER ARM. SKIN IS WARM AND DRY WITHOUT PALLOR. THERE ARE BRISK CAPILLARY REFLEXES IN HER LEFT DIGITS. PULSES ARE EQUAL AND BILATERAL. THERE IS NO CYANOSIS. SHE REPORTS THAT THIS MAY BE RELATED TO AN OLD IV SITE. THERE IS NO EMANATING CELLULITIS OR ANY UNTOWARD APPEARING LESION. EXTENSIVE EXAM DID NOT REVEAL ANY SIGNIFICANT SWELLING, ERYTHEMA, OR IMPAIRED CIRCULATION. HOWEVER, DUE TO THE NEW BIVENTRICULAR SYSTEM, WE WOULD RECOMMEND A VENOUS ULTRASOUND TO EVALUATE FOR ANY POSSIBLE THROMBUS. ALL AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS ACTIVELY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222665 LUMAX 540 HF-T CRT-D NIK BIOTRONIK SE & CO. KG 360347

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other