BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4082322 · Received September 11, 2014

    Report

    Report Number
    3004209178-2014-16873
    Event Type
    Injury
    Date Received
    September 11, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS:: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. PRODUCT ID: 8583, LOT# N280019, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A CATHETER REVISION ON (B)(6) 2015. THE EXISTING CATHETER WAS COILED UP IN THE LUMBAR AREA DESPITE "PERFECT ANCHORING." A NEW CATHETER WAS USED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REVISION HAD NOT YET BEEN SCHEDULED AT THE PATIENTS REQUEST. THE PATIENT'S SPASTICITY CONTROL WAS STILL NOT GOOD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT STARTED LIORESAL ON 2014-(B)(6). IT WAS NOTED THE SURGICAL INTERVENTION HAD NOT YET OCCURRED, BUT A CATHETER REVISION WAS ANTICIPATED. THE PATIENT HAD NOT RECOVERED AND THE SYMPTOMS/ISSUE WAS ONGOING. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED FOR A CATHETER REVISION IN (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS MIGRATION/DISLODGEMENT OF THE CATHETER TIP AND A CATHETER REVISION WAS PLANNED. DIAGNOSTIC TESTING INCLUDED X-RAYS, WHICH CONFIRMED THE DISLODGEMENT AND THE CAUSE OF THE ISSUE WAS UNDETERMINED. IT WAS NOTED THE PATIENT HAD A LOSS OF INTRATHECAL BACLOFEN EFFECT AND INCREASED SPASTICITY. THE PATIENT¿S STATUS WAS ¿ALIVE-WITH INJURY.¿ THE PUMP WAS BEING USED TO DELIVER LIORESAL. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562836 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention