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

Model Number 8637-40

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Overdose (1988); Decreased Respiratory Rate (2485); Cognitive Changes (2551)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a company representative regarding a patient receiving lioresal 2000mcg/ml at 300cmg/day via an implantable pump. The indications for use were intractable spasticity and cerebral palsy. On (b)(6) 2020 it was reported that the patient reported to the er (emergency room) on (b)(6) 2020 with altered mental status, hypotension, and respiratory depression which required intubation. The patient was thought to have signs and symptoms itb (intrathecal baclofen) overdose. Per report, the patient was transferred to the neuro icu (intensive care unit). Per report there were no factors that contributed to the event. No troubleshooting was performed but an x-ray was completed showing the catheter intact. The actions and interventions taken to resolve the issue was it was suspected that the patient had a pump and or catheter issue, so the physician took the patient to or (operating room) today, (b)(6) 2020 to replace the pump and explore the potential catheter issue. Per the physician, there was no catheter issue found as the catheter was patent and he was able to withdraw 2cc from catheter access port, so the decision to just replace the pump was made. The issue was resolved at the time of the report and it was noted that the healthcare provider would have no further information regarding the event. The patient status was noted as alive, no injury and no further complications were reported or anticipated.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 9659722
• MDR Text Key: 185548527
• Report Number: 3004209178-2020-02385
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2013
• 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: 02/03/2020 Patient Sequence Number: 1