BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1971596 · Received January 25, 2011

    Report

    Report Number
    3007566237-2011-00581
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 20, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IN REGARDS TO A WOUND INFECTION, AN ONSET OF (B)(6) 2011 WAS NOTED. SEVERITY WAS CONSIDERED TO BE SEVERE; AND THE PATIENT REQUIRED HOSPITALIZATION/PROLONGED HOSPITALIZATION FOR TREATMENT OF THE EVENT. GABALON WAS DISCONTINUED ON (B)(6) 2011; AND "WITHDRAWAL DUE TO INFECTION" WAS INDICATED. FOLLOWING A PUMP AND CATHETER EXPLANT PROCEDURE ON (B)(6) 2011, THE PATIENT LATER RECOVERED FROM THE INFECTION ON (B)(6) 2011. THE PATIENT'S DEVICES WERE NOT REPLACED. CAUSALITY OF THE WOUND INFECTION WAS INDICATED AS NOT BEING RELATED TO DRUG, PROCEDURE, OR DEVICE SYSTEM (PLEASE REFER TO MFR REPORT # 3007566237-2011-00651 IN REGARDS TO AN ALTERNATE RELATED EVENT REGARDING INFECTION).

    Description of Event or Problem · 1

    THE PT HAD A POSSIBLE POCKET INFECTION. THE PUMP AND CATHETER WERE GOING TO BE REPLACED. THE DEVICE SYSTEM WAS USED TO DELIVER GABALON. ADDITIONAL INFORMATION HAS BEEN REQUESTED A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Hospitalization| O| R CATHETER: MODEL 8711, LOT#N180742004| IMPLANTED:| EXPLANTED: