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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 8637-40
Device Problems Fluid Leak (1250); Kinked (1339); Aspiration Issue (2883)
Patient Problem Pain (1994)
Event Date 03/01/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8637-40, serial# (b)(4), implanted: (b)(6) 2014, product type: pump. Other relevant device(s) are: product id: 8637-40, serial/lot #: (b)(4), (b)(6), (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a clinical study regarding a patient receiving hydromorphone (10. 0 mg/ml at 2. 0 mg/day), fentanyl (1515. 0 mcg/ml at 310. 0 mcg/day), and bupivacaine (9 mg/ml at 1. 8 mg/day) via an implanted pump. The indication for use was spinal pain. It was reported the patient's pain was more intense compared to the pain they had previously had. It was noted the change was due to a fall. No environmental factors were contributing to the loss of pain control. A catheter dye study was performed, on (b)(6) 2018, and a leak was detected. It was noted the pump originally didn't aspirate and only when manipulated did fluid start to come out. There was also a leak at the anchor site at l1 with intrathecal contrast noted. A kink was found at the collette. It was indicated the event was possible related to the device or therapy and unlikely related to the implant procedure. The device diagnosis was catheter leakage and the clinical diagnosis was increase in pain. The patient's catheter was explanted and not replaced on (b)(6) 2018. It was noted the catheter was returned to the manufacture. The issue resolved without sequelae on (b)(6) 2018. It was noted the patient was also taking hydrocodone, keflex, mvi, omepreazole, sertraline, vistaril, wellbutrin at the time of the event. The patient's medical history included post laminectomy syndrome, sleep apnea, arachnoidits, seizure disorder, depression. The patient's weight was noted as (b)(6).
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from healthcare provider (hcp) via clinical study indicated the catheter was explanted and replaced on (b)(6) 2018. No further complications were reported/anticipated.
 
Manufacturer Narrative
The catheter was returned, and analysis found a kink in the catheter body and a hole-not user related in the catheter body. If information is provided in the future, a supplemental report will be issued.
 
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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
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7518610
MDR Text Key108404708
Report Number3007566237-2018-01471
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/16/2018 Patient Sequence Number: 1
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