BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1924795 · Received December 8, 2010

    Report

    Report Number
    3007566237-2010-10255
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0592-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS INTERROGATED ON (B)(6) 2010 WHEN THE PT CAME IN TO THE CLINIC. THE PUMP SAID IT WAS STOPPED. THE PT HAD HAD AN MRI 2 WEEKS EARLIER BUT NEVER CAME IN TO THE HOSPITAL TO GET HIS PUMP CHECKED. THE PUMP WAS REPLACED. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. 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 41 YR Required Intervention EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT # UNK| CATHETER: MODEL 8731SC, LOT # UNK