BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5004667 · Received August 14, 2015

    Report

    Report Number
    3004209178-2015-16063
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 22, 2015
    Report Date
    April 13, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N140414, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID: 8590-1, LOT# N140414, IMPLANTED: (B)(6) 2008, : PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6)2008, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: CATHETER.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A COMPANY REPRESENTATIVE REPORTED THAT AS PER A HEALTHCARE PROVIDER (HCP) THE PATIENT WAS CURRENTLY RECEIVING LIORESAL WITH CONCENTRATION 500 MCG/ML VIA THEIR IMPLANTED PUMP AT A DOSE RATE OF 199.84 MCG/DAY FOR INTRACTABLE SPASTICITY. THE DRUG LOT NUMBER OF BACLOFEN WAS UNKNOWN. THE PATIENT'S PUMP POCKET WAS SWOLLEN. THE PATIENT DID NOT EXPERIENCE ANY WITHDRAWAL SYMPTOMS. A CATHETER ISSUE WAS CONFIRMED. THE DATE OF EVENT WAS (B)(6) 2015. THE CATHETER HAD A TEAR/HOLE/FRACTURE WHICH WAS DIAGNOSED VIA SURGICAL EXPLORATION. UPON OPENING THE POCKET IT WAS DISCOVERED THAT THE CATHETER WAS BROKEN. ON (B)(6) 2015, THE COMPANY REPRESENTATIVE HAD CALLED FROM THE CATHETER REVISION; ENTERING A NEW CATHETER LENGTH REGARDING THE NEW PUMP SEGMENT WAS BEING CONSIDERED. TROUBLESHOOTING RESOLVED THE REPORTED EVENT. THE SURGEON ADDED AN ADDITIONAL PROXIMAL CATHETER SEGMENT TO EXISTING PROXIMAL SEGMENT AND SPLICED THEM TOGETHER SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 22-MAR-2017 FROM A LEGAL FIRM INDICATED THE PATIENT HAD BEEN HOSPITALIZED. EXPLANT SURGERY DATE OF (B)(6) 2016 WAS NOTED. THE ISSUE WAS INDICATED AS 'UNDER INVESTIGATION'. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538107 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R