BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1920108 · Received December 3, 2010

    Report

    Report Number
    3007566237-2010-10180
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN (B)(6), IT WAS REPORTED THAT AT THE LAST PUMP REFILL (DATE NOT REPORTED) THE HEALTHCARE PROVIDER (HCP) WITHDREW 10 CC OF FLUID FROM OUTSIDE THE PUMP. TESTS DIDN'T REVEAL ANY INFECTION. IN (B)(6), IT WAS REPORTED THAT THE PATIENT HAD THE PUMP REFILLED ON (B)(6) 2010. THE PATIENT WENT HOME AND WENT TO BED. THE PATIENT WENT INTO A COMA-LIKE STATE AND WAS TAKEN TO THE HOSPITAL. AN EKG AND MRI WERE PERFORMED AND NOTHING WAS DETECTED. IT WAS UNK IF A PROCEDURAL ISSUE DURING THE REFILL CAUSED THE PROBLEM. THE PUMP MANAGING PHYSICIAN WAS UNAWARE OF WHAT CAUSED THE ISSUE. THE PATIENT WAS IN THE HOSPITAL FOR SEVERAL DAYS. THE SYMPTOMS HAD SINCE GONE AWAY. 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 LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization IMPLANTED:| CATHETER: MODEL #8709, LOT #L68734| EXPLANTED: