BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B

    MDR report key: 8026458 · Received October 31, 2018

    Report

    Report Number
    1627487-2018-11069
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 7, 2018
    Report Date
    April 1, 2020
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    05415067020680
    PMA / PMN Number
    P140009
    Removal / Correction Number
    1627487-10/16/18-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A CORRECTIVE/PREVENTIVE ACTION PLAN HAS BEEN INITIATED BY THE MANUFACTURER TO ADDRESS THIS ISSUE. THE MANUFACTURER HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Additional Manufacturer Narrative · 1

    DESCRIPTION SHOULD HAVE INCLUDED 'DEEP BRAIN STIMULATION' RATHER THAN 'DEEP BRIAN STIMULATION' IN THE INITIAL REPORT SUBMISSION. CONCOMITANT DEVICES AND THERAPY DATES HAVE BEEN ADDED.

    Description of Event or Problem · 1

    DEVICE 1 OF 2: REFERENCE MFR REPORT: 1627487-2018-11070. THIS RECORD IS BEING PROACTIVELY INITIATED BASED ON THE ACKNOWLEDGED IMPLANTED OR UNKNOWN STATUS WHICH WAS IN RESPONSE TO THE MEDICAL DEVICE RECALL REMOVAL ACTIVITY, LETTER DATED (B)(6) 2018. THE LISTED SERIAL NUMBER FOR THE INFINITY DBS (DEEP BRIAN STIMULATION) LEAD MAY CONTAIN AN ELECTRODE THAT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO CONSEQUENCES OR IMPACT TO THE PATIENT HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. RELATED MANUFACTURER REFERENCE NUMBER 1627487-2018-11070. ADDITIONAL INFORMATION RECEIVED (SN (B)(4), DEVICE 1) INDICATED THE RADIOGRAPH IS CONFIRMED TO BE THE INCORRECT MATERIAL; THEREFORE, THE MATERIAL SEGREGATION ISSUE DESCRIBED IN FSCA 1627487-10/16/18-001-R DID AFFECT THIS LEAD. THE PROGRAMMING HISTORY REVIEW WAS PERFORMED AND NO EVIDENCE OF THERAPEUTIC PROGRAMMING ON THE MOST PROXIMAL UNSEGMENTED ELECTRODE WAS FOUND. STIMULATION PARAMETERS DID NOT ACTIVATE THE MOST PROXIMAL ELECTRODE AND THAT ELECTRODE IS CONSTRUCTED OUT OF A KNOWN BIOCOMPATIBLE MATERIAL, ASIDE FROM MAINTAINING THE PROGRAMMING RESTRICTION THERE IS NO ADDITIONAL ACTION NECESSARY FOR THIS PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATED THE RADIOGRAPH IS NORMAL (SN (B)(4) DEVICE 2); THEREFORE, THE MATERIAL SEGREGATION ISSUE DESCRIBED IN FSCA 1627487-10/16/18-001-R DID NOT AFFECT THIS LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863386 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B DBS LEAD MHY ST. JUDE MEDICAL - NEUROMODULATION 6172 6478084 05415067020680

    Patients

    Seq Age Sex Outcome Treatment
    1