BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2090902 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-03111
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPERIENCED A WARM/HOT/BURNING SENSATION OVER THE LOCATION OF THE PUMP FOLLOWING AND MRI SCAN, THAT OCCURRED ON (B)(6) 2011. THE SCAN SEQUENCE AND DURATION WAS NOTED AS 2 SCANS APPROX 40 MINUTES EACH IN DURATION. THE PT OUTCOME WAS NOT REPORTED. THE DRUGS ADMINISTERED VIA THE PUMP WERE AS FOLLOWS: HYDROMORPHONE (DILAUDID), CLONIDINE, AND BUPIVACAINE (MARCAINE). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J0178003R| IMPLANTED:| CATHETER: MODEL 8575, LOT# N108004| PROGRAMMER: MODEL 8832, LOT# NJG004622N| EXPLANTED: