BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1892233 · Received November 2, 2010

    Report

    Report Number
    3004209178-2010-08756
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A CONFIRMED GRANULOMA AROUND THE TIP OF HIS INTRATHECAL CATHETER. THE PT PRESENTED WITH LOWER EXTREMITY WEAKNESS, AND THE DOCTOR SENT HIM FOR A CT. THE CT DID APPARENTLY CONFIRM THE FORMATION OF A GRANULOMA. THE PUMP DELIVERED DILAUDID AT A CONCENTRATION OF 10 MG/ML AND A DOSE OF 3 MG/DAY. HE WAS SCHEDULED TO SEE A DOCTOR AND EXPLANT AS SOON AS POSSIBLE, BUT NO SURGERY DATE HAD BEEN SCHEDULED. THE PT WAS STILL RECEIVING 3 MG/DAY OF DILAUDID UNTIL A NEW TACK OF ORAL MEDICATION CAN BE TAKEN. THE REASON HE WAS PUT ON A PUMP WAS THAT HE DID NOT TOLERATE ORAL OPIOIDS TO THE POINT OF BENEFIT. ADD'L INFO 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 CATHETER: MODEL 8711, LOT# N132174019| IMPLANTED:| EXPLANTED: