BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 3083071 · Received April 29, 2013

    Report

    Report Number
    1028232-2013-01165
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 17, 2013
    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

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION SHOWED CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE PROXIMAL AND DISTAL SHOCK COILS. BASED ON THE SYMPTOMS, IT IS REASONABLE TO ASSUME THAT THIS DAMAGE RESULTED FROM THE EXPLANTATION PROCEDURE. FURTHER ANALYSIS OF THE LEAD DID NOT REVEAL ANY IRREGULARITY THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. IN PARTICULAR, THE VALUES OF THE PARAMETERS MEASURED DURING THE ELECTRICAL ANALYSIS OF THE LEAD PROVED TO BE WITHIN THE TECHNICAL SPECIFICATIONS. IN SUMMARY, CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE PROXIMAL AND DISTAL SHOCK COILS WERE OBSERVED, WHICH RESULTED MOST LIKELY FROM 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 NON-CAPTURE. THE HOSPITAL RETAINED THE DEVICE. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO NON-CAPTURE. THE HOSPITAL RETAINED THE DEVICE. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED. THIS DEVICE WAS RETURNED WITH OOS DOCUMENTATION FROM SORIN MEDICAL. PER OOS, THIS LEAD WAS EXPLANTED DUE TO HIGH THRESHOLDS AND LOSS OF CAPTURE. THIS LEAD WAS REPLACED WITH SORIN VIGILA 1 CR 65, SN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183602 LINOX SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization