BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3223515 · Received July 12, 2013

    Report

    Report Number
    3007566237-2013-02326
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO SIGNIFICANT ANOMALY; PUMP EXTERIOR IMPACT DENTS, DID NOT AFFECT POST-EXPLANT PERFORMANCE. THE PUMP PASSED ALL NON DESTRUCTIVE TESTING. NO SIGNIFICANT ANOMALIES WERE FOUND WITH THE PUMP DURING THE DESTRUCTIVE ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT A PUMP PROBLEM WAS SUSPECTED FROM "LAST SUMMER".

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S FAMILY HAD COMPLAINED THAT THEIR SON WAS NO LONGER RECEIVING DRUG AND HAD INCREASED SPASTICITY. THE PATIENT HAS HAD MULTIPLE CATHETER REVISIONS WITH LITTLE TO NO AFFECT. HIS CATHETER WAS EVENTUALLY MOVED FROM THE INTRATHECAL SPACE TO THE VENTRICLE A FEW YEARS AGO. THE PATIENT WAS HAVING SYMPTOMS OF INCREASED SPASTICITY AND SEROMA AND THE PATIENT'S PARENTS HAVE STATED THEIR SON WAS STILL NOT SEEING RELIEF. DIAGNOSTIC TESTING AND TROUBLESHOOTING WAS PERFORMED INCLUDING A CT SCAN. THE HCP DECIDED TO REPLACE THE PUMP AND SEND IT BACK FOR ANALYSIS. A NEW PUMP WAS PLACED ON (B)(6) 2013 AS WELL AS A NEW CATHETER INTO THE VENTRICLE. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY/NO ADVERSE EVENT. THE PUMP WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION LATER RECEIVED INDICATED THAT THE REPORTER DID NOT KNOW WHAT DRUG WAS IN THE PREVIOUS PUMP. THE OFFICE TYPICALLY REFILLED WITH GABLOFEN BUT LIORESAL WAS USED IN THE NEW PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323937 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention