BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1061701 · Received June 13, 2008

    Report

    Report Number
    2182207-2008-03222
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    April 1, 2006
    Report Date
    May 14, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING PUMP REPLACEMENT, THE PT EXPERIENCED LACK OF PAIN CONTROL. THE DOSE WAS REPROGRAMMED FROM 24 MG/DAY OF DILAUDID TO 25 MG/DAY; BUPIVICAINE 19.2 MG/DAY TO 20 MG/DAY; CLONIDINE 686 MCG/DAY TO 1431 MCG/DAY AND DROPERIDOL 171 MCG/DAY TO 179 MCG/DAY. THE PT WAS ALSO TAKING MSIR 15 MG TABLETS TWICE A DAY. THE PT SUBSEQUENTLY HAD TWO FALLS "BUT NOT NECESSARILY DUE TO LEG WEAKNESS". APPROX ONE MONTH LATER, THE PT REPORTED 70% IMPROVEMENT IN BILATERAL LEG STRENGTH WITH A MODERATE INCREASE IN LOW BACK AND LEFT LEG PAIN FOLLOWING BUPIVICAINE CONCENTRATION DECREASE. THE PT SUFFERED ANOTHER FALL SEVERAL DAYS LATER RESULTING IN A SMALL SUBDURAL HEMATOMA, FRACTURE OF LEFT 1ST METATARSAL AND LEFT 1ST TOE, RIB FRACTURE AND FOREHEAD HEMATOMA. THE PT CONTINUED TO HAVE PAIN FROM THE FALL. SHE WAS MONITORED AND ADJUSTMENTS WERE MADE TO ORAL MEDICATIONS DUE TO ADVERSE SIDE EFFECTS OF SEDATION. MEDICATION LIST INCLUDED: CATAPRES; PROCARDIA; PREVACID; NORTRYPTLINE, SOMA, VICODIN ES, TORADOL, OXYCONTIN, LORAZEPAM, SINEQUAN, BACLOFEN, VISTARIL, ZOFRAN, EFFEXOR, PRILOSEC, MSIR, VALIUM.

    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 Required Intervention EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT #UNK| CATHETER: MODEL 8709, LOT # N058668033, IMPLANTED: