BEUDAMED
    FDA Adverse Event Other Summary report: N

    KENTROX SL-S 65/16 STEROID

    MDR report key: 2907292 · Received December 27, 2012

    Report

    Report Number
    1028232-2012-03434
    Event Type
    Other
    Date Received
    December 27, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS FOUND DISSECTED INTO TWO FRAGMENTS. ALL FRAGMENTS OF THE LEAD WERE RETURNED FOR ANALYSIS. THE RETURNED LEAD FRAGMENTS WERE ANALYZED. THE INSPECTION OF THE LEAD FRAGMENTS DEMONSTRATED MULTIPLE SIGNS OF WEAR. THE INSULATION WAS FOUND RUBBED THROUGH. THE CONDUCTOR TO THE RV SHOCK COIL WAS FOUND FRACTURED IN THIS AREA. 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. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. FURTHER DAMAGES RESULTED MOST LIKELY DURING SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    PER BOSTON SCIENTIFIC, THIS LEAD WAS EXPLANTED DUE TO A "PRODUCT PERFORMANCE ISSUE." THE BOSTON SCIENTIFIC ICD WAS EXPLANTED AT THE SAME TIME DUE TO PREMATURE BATTERY DEPLETION. PER THE EXPLANTING PHYSICIAN'S OFFICE, THE NATURE OF THE MALFUNCTION IS UNKNOWN, AS THE ONLY NOTES STATE THAT THE BOSTON SCIENTIFIC REP RECOMMENDED THAT BOTH DEVICE AND LEAD BE EXPLANTED DUE TO PREMATURE BATTERY DEPLETION OF THE ICD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization