BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3071420 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06680
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    July 28, 2010
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS MADE TO CORRECT THE DEVICE INFORMATION, AND UPDATE THE MANUFACTURING SITE. THE PREVIOUSLY REPORTED DEVICE INFORMATION WAS INCORRECT. BASED ON THE INFORMATION, THE PREVIOUSLY REPORTED DEVICE HAD NOT YET BEEN IMPLANTED AT THE TIME OF THE EVENT. (B)(4). THE MANUFACTURING SITE ID WAS PREVIOUSLY REPORTED AS #3004209178. UPON FURTHER REVIEW, THE CORRECT MANUFACTURING SITE ID IS #3007566237.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8703W, LOT# L61564, IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT ON (B)(6) 2010 THIS PATIENT WAS HOSPITALIZED AS HE EXPERIENCED NUMBNESS IN HIS EXTREMITIES. AT THAT TIME THE PATIENT UNDERWENT DIAGNOSTIC TESTING WHICH INCLUDED A COMPUTERIZED TOMOGRAPHY (CT) SCAN WITH AND WITHOUT CONTRAST AND MYELOGRAMS. IN ADDITION, DURING THE HOSPITALIZATION THE PUMP REPORTEDLY MALFUNCTIONED AND WAS BELIEVED TO HAVE ADMINISTERED A BOLUS OF MEDICATION CAUSING PERMANENT AND CONTINUING INJURY. IN ADDITION, THE PATIENT ALLEGEDLY EXPERIENCED PHYSICAL PAIN AND SUFFERING, MENTAL ANGUISH, AND EMOTIONAL DISTRESS. IT WAS NOT PROVIDED WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171459 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization