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

Model Number 8637-40

Device Problems Fluid Leak (1250); Excess Flow or Over-Infusion (1311); Device Ingredient or Reagent Problem (2910)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, lot#: n274486004, implanted: (b)(6) 2011, explanted: (b)(6) 2022, product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative (rep), healthcare provider (hcp)) regarding a patient who was receiving dilaudid (1 mg/ml at 0. 0588 mg/day) via an implantable pump for non-malignant pain. It was reported that during a recent refill in (b)(6) 2021, the home infusion nurse notified the hcp that they aspirated cloudy fluid from the pump with no obvious explanation. This was followed by a less than expected 8 ml volume discrepancy. Subsequently, the hcp had the home infusion nurse refill the pump with normal saline until surgical revision could be completed to determine the cause of the volume discrepancy and cloudy fluid presence. There were no known factors that may have led or contributed to the issue.  the hcp opened the pump pocket and noted a presence of cloudy fluid. They did not feel as though this was infectious in nature. No swabs or cultures were collected. The pump was disconnected from the intrathecal catheter to allow the hcp to dissect out the existing catheter. Once the catheter was dissected out, the hcp was again able to easily aspirate spinal fluid from the intrathecal catheter. The hcp was given a new intrathecal pump, which was attached to the existing intrathecal catheter. At this time, the hcp again aspirated cerebrospinal fluid from the catheter port site. When the hcp attempted to push the fluid back through the port, they noticed leaking around the bell/hub where the catheter attaches to the pump. Subsequently, the hcp opted to replace the proximal pump segment of the existing catheter. The hcp was given an 8596sc intrathecal catheter pump segment revision kit. They trimmed approximately 1 cm from the spinal segment and attached the new proximal pump segment. The new pump was then attached to the new proximal pump segment, at which time the hcp again aspirated cerebral spinal fluid through the catheter access port. The hcp repeated the process of pushing the fluid back through the catheter port site, and there was no further leaking noted at the connection between the spinal segment and proximal pump segment or at the catheter bell/hub where the catheter attaches to the pump. The pump was then placed back in the pocket and the incision was closed. The issue was resolved at the time of report. The patient's weight and medical history were asked but unknown. The patient's status at the time of report was alive - no injury.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14251425
• MDR Text Key: 290447524
• Report Number: 3004209178-2022-05470
• 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,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/10/2017
• 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: 04/29/2022 Patient Sequence Number: 1