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

Model Number 8637-40

Device Problems Kinked (1339); Unstable (1667); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 8780, serial# (b)(4), implanted: (b)(6) 2016, product type catheter. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from an unknown source via a device manufacturer representative regarding a patient who was receiving an un known drug via an implantable infusion pump for post lumbar laminectomy syndrome and spinal pain. It was reported that the patient had been having sporadic to no pain relief. The pump was flipped and the catheter was kinked. The catheter was very coiled at the pump pocket. It was unknown when the patient's sporadic to no pain relief, pump flip, catheter kink, or catheter coil at the pump pocket started. The issue was diagnosed through surgical exploration, which occurred on (b)(6) 2018 during the revision, the healthcare provider (hcp) used a revision kit. The starting length was 73. 7 cm, and the hcp removed 54. 5 cm, which left 19. 2 cm. However, the hcp manually measured the pump segment to be implanted and it measured 18. 6 cm. The hcp was concerned about the 0. 6 cm discrepancy. No further complications were reported.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016, product type: catheter. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) via a device manufacturer representative. It was reported that the cause of the flipped pump and catheter kinking/coiling was not determined. The flipped pump and catheter kinking/coiling were resolved with surgery on (b)(6) 2018. Part of the catheter was explanted and replaced with a pump segment catheter. The cause of the catheter length discrepancy was not determined. The catheter length was calculated based on what the hcp trimmed and input under the catheter information. Per the hcp, there was not going to be a product return. No further complications were reported.

• 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: 7324244
• MDR Text Key: 101890654
• Report Number: 3004209178-2018-04681
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/14/2018
• 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: 03/08/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/21/2016
• 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: 03/08/2018 Patient Sequence Number: 1