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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Difficult to Advance (2920); Positioning Problem (3009)
Patient Problems Neuropathy (1983); Pain (1994); Arachnoiditis, Spinal (2390)
Event Date 10/05/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8781, serial #: (b)(4), implanted: (b)(6) 2018, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 10-sep-2020, udi#: (b)(4). Additional patient codes: (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 gablofen via an implanted pump. The indication for use was intractable spasticity and multiple sclerosis. It was reported, on (b)(6) 2018, one date post catheter revision, the patient noted 10/10 nerve pain. The clinical diagnosis was new radiculopathy secondary to catheter placement. Three days later the patient was scheduled for a catheter revision secondary to left lower radiculopathy after catheter placement. The catheter was removed without paresthesia. It was noted a catheter revision was attempted but abandoned secondary to the spinal segment being removed. The implanter made four attempts to thread the catheter up to the intrathecal space, but each time the patient reported severe pain down either the right or left lower extremity. The procedure was abandoned and the spinal segment was removed at the connecting "pain" and the pin was anchored to the fascia. The post-op diagnosis was likely arachnoiditis t10-l2 with inability to float it catheter at those levels. Planned to refer to a neurosurgeon for placement of c1 catheter. The patient's therapy was suspended and programmed to minimum rate. The patient was administered lyrica on (b)(6) 2018. It was noted the event was related to the implant procedure. On (b)(6) 2018, the lumbar incision had opened and drained fluid. The wound was re-dressed with sterile gauze, pressure dressing, tegaderm, and tape. The issue resolved without sequelae on (b)(6) 2018.
 
Manufacturer Narrative
Concomitant medical produts: product id 8781, serial# (b)(4), implanted: (b)(6) 2018, product type catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider via a clinical study reported the exact cause of the nerve pain/radiculopathy and the catheter not being threaded into the it spaced were not known. The patient's baseline weight was not measured.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8024420
MDR Text Key125662718
Report Number3004209178-2018-24323
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 health professional,study
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/24/2018
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: 10/31/2018 Patient Sequence Number: 1
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