BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3915735 · Received July 7, 2014

    Report

    Report Number
    3004209178-2014-12583
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. ANALYSIS OF THE SUTURELESS CATHETER CONNECTOR FOUND NO SIGNIFICANT ANOMALY; ANALYSIS FOUND NON-SIGNIFICANT INDENT IN SEAL THAT DID NOT AFFECT INFUSION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, LOT # N183299025, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, LOT # N183299025, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    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 REPORTED THE PUMP AND CATHETER WERE EXPLANTED ON (B)(6) 2014. THE PATIENT EXPERIENCED ACUTE PARALYSIS THAT RESOLVED IN 4-5 DAYS. AN MRI REVEALED INFLAMMATION ADJACENT TO THE CATHETER IN THE PARASPINOUS MUSCLE BUT NOTHING THAT WOULD INDICATE THE DEVICE SYSTEM WOULD BE THE CAUSE OF THE PARALYSIS. THE DRUG WAS TITRATED DOWN AND THE PATIENT DID NOT EXPERIENCE ANY OTHER SYMPTOMS. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE- NO INJURY.¿ THE PUMP WAS BEING USED TO DELIVER BACLOFEN AND CLONIDINE. IT WAS LATER REPORTED THE CAUSE OF THE EVENT HAD NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393603 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention