BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4073003 · Received September 9, 2014

    Report

    Report Number
    3004209178-2014-16623
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. PRODUCT ID: 8703W, LOT# L49380, IMPLANTED: (B)(6) 1998, PRODUCT TYPE: CATHETER. PRODUCT ID: 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POTENTIAL GRANULOMA IDENTIFIED ON THE MRI LOCATED AT THE CATHETER TIP. THE PATIENT HAD PAIN LOCATED IN THE LOW BACK ASSOCIATED WITH THE EVENT. THE PATIENT WAS REFERRED TO A NEUROSURGEON FOR EVALUATION. THE MANAGING PHYSICIAN DISAGREED WITH THE RADIOLOGIST REGARDING READING OF THE MRI RESULTS. THE MANAGING PHYSICIAN BELIEVED THAT THE LUCENCY SEEN WAS SIMPLY THE CATHETER TIP. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS "ALIVE-NO INJURY." THE RADIOLOGIST REPORT IMPRESSION WAS THAT THERE WAS SEVERE CENTRAL CANAL STENOSIS OF L3-L4. ENHANCING GRANULATION ISSUE OF L4-L5 ENCIRCLING THE LEFT L5 ROOT SLEEVE. THE L4-L5 CIRCUMFERENTIAL DISC BULGING WITH MORE FOCAL BULGE/PROTRUSION TO THE LEFT EXTENDING INTO THE ORIGIN OF THE LF-L5 NEURAL FORAMINA. ALSO ENHANCING GRANULATION TISSUE LEFT OF L5-S1 ENCIRCLING THE LEFT S1 ROOT SLEEVE AND EXTENDING INTO THE LEFT L5-S1 NEURAL FORAMINA. IN ADDITION TO NEURAL FORAMINAL NARROWING PARTICULARLY ON THE LEFT AT THE L5-S1 LEVEL WITH COMPRESSION OF THE LEFT L5 DORSAL ROOT GANGLION. THERE IS MINIMAL INTERVAL CHANGE SINCE THE PRIOR EXAMINATION. IT WAS UNKNOWN WHAT THE PUMP SYSTEM WAS DELIVERING. (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
    555302 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Other