BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2212629 · Received August 11, 2011

    Report

    Report Number
    3007566237-2011-06245
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    January 1, 2010
    Report Date
    July 20, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT ON (B)(6) 2010 THE PUMP WAS INTERROGATED AND NOTED T BE STALLED. IT WAS STATED THAT THE PT WAS INPATIENT FOR "SOMETHING ELSE", AND THEY NOTICED THE PUMP STALL. THEY READ THE LOGS THAT ALSO SHOWED A PUMP STALL BACK IN (B)(6) 2010. RECOVERIES WERE NOTED ON (B)(6) 2010 AND ON (B)(6) 2010. THE PUMP WAS SET IN MINIMUM RATE AND THE PT WAS PUT ON ORAL MEDICATIONS. THE DRUG INFUSED WAS DILAUDID. PT WAS DOING FINE AND IT WAS LATER DECIDE TO HOLD OFF ON ANYTHING AS THE PT MAY BE "A CANDIDATE FOR FUTURE EXPLANT". ON (B)(6) 2011, IT WAS REPORTED THAT THE PT HAD SALINE IN THE PUMP CURRENTLY. HE HAD "AN ISSUE LAST YEAR (2010) AND IT CAUSED HIM TO BE IN THE HOSPITAL FOR (B)(6)". PT WAS DEBATING ON GETTING IT REPLACED OR START USING IT AGAIN, BUT WAS CONCERNED OF ANOTHER STALL.

    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 65 YR Hospitalization| R CATHETER: MODEL 8731, LOT# N001798330| IMPLANTED:| EXPLANTED: