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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 863720
Device Problems Kinked (1339); Obstruction of Flow (2423); Difficult to Advance (2920); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2018
Event Type  Injury  
Manufacturer Narrative
Other applicable components are: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2018. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 20-dec-2019, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving gablofen (500mcg/ml at an intended dose of 50mcg/day) via intrathecal drug delivery pump. The indication for use was noted as scoliosis and anoxic brain injury. It was reported that at the brand new implant on (b)(6) 2018, the catheter was kinking/going lateral or inferior and they were meeting resistance when trying to advance it to the proper it level. The hcp thought maybe a laminectomy and re-positioning the patient's body, etc. Would work but no methods worked, so they connected the catheter to the new pump that they filled with intrathecal (it) baclofen drug and placed the pump in the pump pocket. They closed the incision and would return in a couple of days to try and feed the catheter into the proper it location. 3d imaging may work, per the hcp. It was thought that the hcp did this before by going in to the pump pocket, trimming off/disconnecting the existing collet, and replacing it with a new collet; utilizing a distal revision piece and advancing it into the proper it location. Pump telemetry/dosing/programming was not done at the time of the report, by instruction of the hcp. No symptoms were reported. There were no further complications reported at this time. Additional information was received from a manufacturer representative. It was reported that the cause of the trouble at catheter implant was presumed to be anatomical. They were unable to get the catheter into the intrathecal (it) space at the time of this report. There were no further complications reported at this time. There were no further complications reported at this time.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider via a company representative. The patient was implanted on (b)(6) 2018 and the surgeon had implanted the pump and proximal/pump segment only. The patient previously had a spinal infusion and the surgeon did not have success implanting the distal/spinal segment of the pump. The surgeon had decided to fill the pump with drug and keep the pump at a minimum rate. The surgeon planned to implant the spinal segment two days later, but the surgery did not happen until (b)(6) 2018. The surgeon now wanted to implant the spinal segment into the cervical spine today to start with intrathecal therapy. No patient symptoms were reported. It was being considered that 1. 044 ml had been dispensed since (b)(6) 2018 and had they filled the pump to capacity on 2018-may-04, 18. 956 ml remained in the reservoir. The indication for use regarding the pump was intractable spasticity and head/brain injury. The pump was currently administering baclofen at a minimum dose rate.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
MDR Report Key7515916
MDR Text Key108386725
Report Number3007566237-2018-01465
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863720
Device Catalogue Number863720
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/15/2018 Patient Sequence Number: 1
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