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

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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 8024420
• MDR Text Key: 125662718
• Report Number: 3004209178-2018-24323
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• 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 Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• 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 Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/24/2018
• 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