BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KENTROX RV 65 STEROID

    MDR report key: 2974003 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00287
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 31, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE KENTROX RV STEROID LEAD WAS FOUND DISSECTED. TWO FRAGMENTS WERE RECEIVED. A SEGMENT OF 1.5 CM BETWEEN THESE TWO FRAGMENTS WAS NOT RETURNED FOR ANALYSIS. IT IS REASONABLE TO ASSUME, THAT THE FRAGMENTATION OF THE LEAD MOST LIKELY ORIGINATED FROM THE EXPLANT PROCEDURE. THE VISUAL INSPECTION SHOWED MULTIPLE SIGNS OF ABRASION ALONG THE LEAD BODY. IN PARTICULAR, AT THE DISTAL FRAGMENT THE INSULATION WAS FOUND RUBBED THROUGH. THIS INSULATION DAMAGE CAN BE CONSIDERED TO BE THE ROOT CAUSE FOR THE OBSERVED OVERSENSING ISSUE AS MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS OF THIS DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. THE CUTTINGS OF THE INSULATION OCCURRED MOST LIKELY DURING THE EXPLANT PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THE PACE/SENSE PORTION OF THIS LEAD WAS CAPPED ON (B)(6) 2012 DUE TO T-WAVE OVERSENSING THAT THE PHYSICIAN WAS UNABLE TO PROGRAM AROUND. THE SHOCK PORTION OF THIS LEAD REMAINED ACTIVELY IMPLANTED. A NEW PACE/SENSE LEAD WAS PLACED. THIS LEAD WAS EXPLANTED ON (B)(6) 2013. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64400 KENTROX RV 65 STEROID ICD LEAD LWS BIOTRONIK SE & CO. KG 348090

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization