BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3852897 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10231
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING PUMP AND CATHETER IMPLANT ON (B)(6) 2014, THE PATIENT DEVELOPED A POST-OP SPINAL HEADACHE DUE TO SURGICAL COM PLICATION. ADDITIONAL PATIENT SYMPTOMS INCLUDED BLURRED VISION AND TROUBLE TRACKING WITH ONE OF HIS EYES. THE PATIENT WAS TO HAVE A BLOOD PATCH DONE ON (B)(6) 2014. THERE WAS NO ALLEGED PRODUCT ISSUE. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS REQUIRED. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS INDICATED AS ALIVE, NO INJURY. THE PUMP WAS USED TO DELIVER LIORESAL ADDITIONAL INFORMATION LATER REPORTED THE SURGICAL COMPLICATION THAT OCCURRED WAS A SPINAL LEAK, AND THEY DID NOT KNOW CAUSATION. A BLOOD PATCH WAS PERFORMED. THE PATIENT REPORTED HAVING BLURRED VISION AND THE PHYSICIAN SAID THE PATIENT COULDN¿T TRACK WITH ONE EYE. YESTERDAY, THE HCP SAID THE PATIENT WAS NOT DOING BETTER DESPITE THE BLOOD PATCH. THE PLAN WAS TO PERFORM A COMPUTERIZED TOMOGRAPHY (CAT) SCAN BUT THE REPORTER DID NOT KNOW IF IT HAD BEEN ORDERED BY THE PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD NO HISTORY OF ANYTHING LIKE THIS EVER HAPPENING BEFORE. PRIMARILY BETWEEN THE 12TH-13TH THE PATIENT EXPERIENCED A SPINAL HA THAT WAS WORSE WHILE STANDING UP, SEVERE ABDOMINAL PAIN AND SPASMS, BLURRED VISION, CROSSED EYED (LEFT EYE MAINLY). TREATMENT INCLUDED INTRAVENOUS FLUIDS, BED REST X2 DAYS, AND CAFFEINE WHICH DID NOT IMPROVE THE SYMPTOMS OR RESOLVE THE ISSUE. THE PATIENT WAS TRANSFERRED TO AN ACUTE CARE FACILITY FOR A COMPLETE WORK-UP. AN MRI WAS PERFORMED AND THE CEREBROSPINAL FLUID WAS TESTED - ALL TESTS WERE NORMAL. IT WAS DETERMINED THAT THE PATIENT'S CRANIAL NERVE ISSUES WERE CAUSED BY DIABETES AND WERE NOT DEVICE RELATED. THERE WERE NO COMPLICATIONS BEFORE, DURING OR AFTER THE PROCEDURE, EXCEPT THE PATIENT BECOMING SYMPTOMATIC. ALL OF THE ISSUES RESOLVED EXCEPT FOR THE CROSS EYED-NESS WHICH IS NOT DEVICE RELATED. THE PATIENT WAS GETTING GREAT SPASTICITY CONTROL AND THERE WERE NO DEVICE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331215 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Required Intervention