BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KENTROX SL-S 65/16 STEROID

    MDR report key: 3211752 · Received July 8, 2013

    Report

    Report Number
    1028232-2013-01872
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    March 27, 2012
    Report Date
    June 25, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    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.

    Description of Event or Problem · 1

    THE PACE/SENSE PORTION OF THIS LEAD WAS CAPPED ON (B)(6) 2012 AND REPLACED WITH ANOTHER LEAD WHILE THE PATIENT WAS UPGRADED TO A CRT-D THE SHOCK PORTION OF THIS LEAD REMAINED ACTIVELY IMPLANTED. LATER THIS SYSTEM WAS EXPLANTED DUE TO AN UNSPECIFIED MALFUNCTION. THE PACE/SENSE RV LEAD BECAME DISLODGED AND THE PHYSICIAN DECIDED TO PROGRAM THE DEVICE TO MAXIMUM OUTPUTS ON THE RV LEAD UNTIL THAT LEAD COULD BE REVISED. THIS DEPLETED MOST OF THE ICD BATTERY, SO THE PHYSICIAN CHOSE TO REPLACE THIS DEVICE WHILE REPLACING THE PACE/SENSE RV LEAD. THIS DEVICE AND THE PACE/SENSE RV LEAD WERE EXPLANTED ON (B)(6) 2013. IT WAS DISCOVERED THAT THE PATIENT WAS OCCLUDED, SO THE PHYSICIAN REFERRED THE PATIENT TO HAVE THE ALL OTHER LEADS EXPLANTED ON (B)(6) 2013 AND A NEW SYSTEM IMPLANTED ON THE RIGHT SIDE ON (B)(6) 2013. THIS LEAD WAS RETAINED BY THE HOSPITAL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308959 KENTROX SL-S 65/16 STEROID ICD LEAD NVY BIOTRONIK SE & CO. KG 345988

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization