BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2760673 · Received September 26, 2012

    Report

    Report Number
    3007566237-2012-02319
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8703W, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AND CONFIRMED THAT THERE WAS NO FLOW AT THE PATIENT'S PROXIMAL CATHETER PIECE AND OBSTRUCTION OCCURRED. AS A RESULT OF THE EVENT, ON THE DAY OF THIS REPORT, THE PROXIMAL SEGMENT WAS REMOVED AND REPLACED WITH A NEW PROXIMAL SEGMENT THAT WAS ATTACHED TO THE PRE-EXISTING DISTAL SPINAL SEGMENT. THE SYMPTOMS OF THE PATIENT WERE UNKNOWN. IT WAS NOTED THAT THE PATIENT'S DRUG DOSE WAS LOWERED FROM 999MCG/DAY TO 250MCG/DAY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. THE DRUG DELIVERED VIA PUMP WAS GABLOFEN. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD SURGERY TO REPLACE THE PUMP DUE TO APPROACHING END OF BATTERY LIFE, AND BOTH CATHETER AND PUMP WERE REPLACED AT THAT TIME. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED TO THE MANUFACTURER FOR ANALYSIS, BUT NEITHER DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER TO DATE. REPORTED SIGNS AND SYMPTOMS ASSOCIATED WITH THE REPORTED EVENT: PATIENT PAST TRAUMATIC BRAIN AND NECK INJURY DURING "ADOLESCENTS" LEFT QUADRIPLEGIC, LIMITED COMMUNICATION, AND CONTRACTURES OF LOWER AND UPPER EXTREMITIES. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. IT WAS REPORTED THAT THE DRUG IN THE PUMP WAS CHANGED FROM LIORESAL TO GABLOFEN ON (B)(6) 2011 WITH A DOSE OF 1000 MCG PER DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention