BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2180971 · Received July 22, 2011

    Report

    Report Number
    3007566237-2011-05693
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A SUSPECTED WITHDRAWAL WAS REPORTED. THE PT WAS REFILLED ON (B)(6) 2011 WITH NO PROBLEMS; HOWEVER, THE NEXT DAY, THE PT BECAME UNCOMFORTABLE AND WAS CRYING. SHE LATER BECAME IRRITABLE, WAS SHIVERING, AND HAD A FEVER. SHE WAS GIVEN OXYCONTIN. PT WAS ADMITTED TO ICU (DATE UNK) AND STARTED ON A VERSA DRIP. HER LAB TESTS INDICATED A CREATINE KINASE (CK) AT 1200 ON (B)(6) 2011 WHICH HAD INCREASED TO 4757 ON (B)(6) 2011. ABOUT 0.3ML OF DRUG WAS INFUSED VIA THE SYSTEM IN THE TIME ELAPSED. IMAGING FOUND NO PROBLEMS. OTHER MEDICAL ISSUES WERE UNK. THE DRUGS INFUSED VIA THE PUMP WERE DILAUDID, CLONIDINE AND COMPOUNDED BACLOFEN. ADDITIONAL 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 MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863740,| LOT# NGV004530N| CATHETER: MODEL 8709, LOT# J53451R08| CATHETER: MODEL 8731, LOT# B002150N01| CATHETER: MODEL 8731, LOT# N059894023| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED: