BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7659344 · Received July 3, 2018

    Report

    Report Number
    3004209178-2018-14933
    Event Type
    Injury
    Date Received
    July 3, 2018
    Report Date
    August 24, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169530119
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709, SERIAL/LOT #: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8703W LOT/SERIAL# (B)(4) IMPLANTED: (B)(4)1997 EXPLANTED: (B)(4)2018 PRODUCT TYPE CATHETER; UBD: UNKNOWN; (B)(4).MDTMDT. EVALUATION OF IMPLANTABLE CATHETER PRODUCT ID 8703W LOT/SERIAL# (B)(4) REVEALED AN AREA WHERE THE CATHETER HAD BEEN ABRADED ON THE DISTAL SEGMENT. THE ABRASION BREACHED THE INNER LUMEN OF THE CATHETER AND LEAKING WAS OBSERVED FROM THE HOLE DURING PRESSURE LEAK TESTING IN THE LAB. ALL CODES, BOTH PREVIOUSLY APPLIED AND CURRENTLY APPLIED, ARE ONLY APPLICABLE FOR PRODUCT ID 8703W LOT/SERIAL# (B)(4). THE EVALUATION CODES HAVE BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING THE PATIENT¿S IMPLANTABLE DRUG INFUSION DEVICE. THE DRUG BEING DELIVERED WAS GABLOFEN WITH AN UNKNOWN DOSE AND CONCENTRATION. THE REASON FOR USE WAS NOT REPORTED. IT WAS REPORTED THAT THE CATHETER WAS REMOVED DUE TO A BREAK/TEAR/HOLE. IT WAS REMOVED ON (B)(6) 2018. THE PARTIAL EXPLANTED FRACTURED CATHETER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME MANUFACTURER. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503465 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169530119

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention