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

Model Number 8637-40

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Overdose (1988); Loss of consciousness (2418)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 10-apr-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient who was receiving 100 mcg/ml baclofen at 50 mcg/day, and 10 mg/ml dilaudid at 5 mg/day via an implantable infusion pump for spinal pain. It was reported that the catheter tip had detached, and the patient had to have a catheter revision done. There were no symptoms from the catheter tip detaching. However, after the catheter revision the patient was not waking up despite being treated with narcan. The patient was intubated. The patient was in the intensive care unit (icu), but as of (b)(6) 2019 the patient had been awake and was doing fine. No further complications were reported.

Manufacturer Narrative

Product id 8780, serial# (b)(4), product type: catheter. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer's representative (rep). It was reported that the cause of the unresponsiveness was not determined. The healthcare professional didn't think it was the pump because the patient had a lot of health issues. 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: 9172011
• MDR Text Key: 161711737
• Report Number: 3004209178-2019-19273
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/14/2019
• 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: 10/09/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/20/2018
• 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: 10/09/2019 Patient Sequence Number: 1