BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX SL 65/16 STEROID

    MDR report key: 2943493 · Received January 9, 2013

    Report

    Report Number
    1028232-2012-03527
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    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 13 CM DISTAL TO THE IS-1 CONNECTOR PIN. BOTH FRAGMENTS WERE RETURNED FOR ANALYSIS. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED DURING SURGERY. THE LEAD FRAGMENTS WERE EXTENSIVELY ANALYZED. THE ANALYSIS REVEALED A DAMAGED INSULATION AT 35 CM DISTAL TO THE IS-1 CONNECTOR PIN. IN THAT SECTION, THE LEAD BODY WAS FOUND SQUEEZED AND DEFORMED. THESE FINDINGS CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED NOISE MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF CLAVICULAR FIRST RIB ENTRAPMENT. FURTHER DAMAGES OCCURRED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO NOISE AND REPLACED. SHOULD ADD'L INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11168 KENTROX SL 65/16 STEROID ICD LEAD LWS BIOTRONIK SE & CO. KG 347351

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization