FDA Adverse Event Malfunction Summary report: N

SYNCHROMED EL

MDR report key: 1083093 · Received July 24, 2008

Report

Report Number
6000030-2008-04360
Event Type
Malfunction
Date Received
July 24, 2008
Date of Event
May 1, 2008
Report Date
June 25, 2008
Manufacturer
RICE CREEK MANUFACTURING
Product Code
LKK
PMA / PMN Number
P860004
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT WAS EXPERIENCING OVERWHELMING PAIN DESPITE REPEATED DOSE INCREASES OF THEIR INTRATHECAL DRUG DELIVERY MEDICATIONS THE PAST FEW MONTHS. THE RESERVOIR VOLUMES HAVE BEEN ACCURATE. MEDICATIONS HAVE BEEN CHANGED. TROUBLESHOOTING WAS BEING CONSIDERED. ADDITIONAL INFORMATION RECEIVED INDICATED THE DRUG USED IN THE PUMP IS FENTANYL 1000 MCG/ML AND BUPIVICAINE 10 MG/ML. IN 2008, THE DOSE OF FENTANYL WAS 385 MCG/DAY AND THE BUPIVICAINE WAS 3.85 MG/DAY. ON SIX DAYS LATER, THE PUMP WAS INCREASED, A BOLUS WAS GIVEN AND BREAKTHROUGH PAIN MEDICATIONS WERE CHANGED FROM HYDROCODONE TO OXYCODONE. THE FOLLOWING DAY, THE PATIENT REPORTED RELIEF FROM THE BOLUS AND INCREASED PUMP RATE. ON TWO DAYS LATER, THE PATIENT'S PUMP WAS INCREASED 34%. ON FOUR DAYS LATER, THE PATIENT REPORTED RELIEF. TEN DAYS LATER, THE PATIENT REPORTED THEY BENT OVER AND HURT THEIR BACK. THE BREAKTHROUGH PAIN MEDICATIONS WERE AGAIN CHANGED DUE TO HALLUCINATIONS. ON THE FOLLOWING MONTH, THE PATIENT UNDERWENT LUMBAR EPIDURAL STEROID INJECTIONS. ON A WEEK LATER, THE PUMP WAS INCREASED 20%. THE HCP REPORTED IT IS UNKNOWN IF THE EVENTS ARE RELATED TO THE DEVICE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK| CATHETER MODEL 8709 LOT# J11486R60| EXPLANTED