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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Fatigue (1849); Overdose (1988); Dizziness (2194); Toxicity (2333); Lethargy (2560)

Event Date 02/14/2019

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 (hcp) on (b)(6) 2019 regarding a patient receiving fentanyl (1000mcg/ml at an unknown dose) via an implanted infusion pump. The indication for use was non-malignant pain. It was reported that the patient may be experiencing a reaction to the medicine or the pump was malfunctioning, and the pump off code was requested. It was noted that (b)(6) (relative to the date of report) the patient began experiencing symptoms of lethargy, drowsiness, dizziness, and drunkenness. The patient went to the emergency department (ed) on the night of (b)(6) 2019, and on (b)(6) 2019 the hcp caught the patient from falling on the floor. The hcp started a narcan drip and contacted technical services. The pump was accessed and the expected reservoir volume and actual reservoir volume were correct, along with all programming including the bridge bolus (bb) with catheter volume as 0. 245ml. It was noted that the fentanyl had been in the pump for about 24 hours, and the hcp did not have access to the programming that was done on (b)(6) 2019. It was noted that they confirmed the correct concentration from the pharmacy that supplied the fentanyl, and later insisted on programming the pump to off state. At the time of report the pump was at minimum rate. 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8350307
• MDR Text Key: 136494281
• Report Number: 3004209178-2019-03502
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/28/2015
• 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: 02/15/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/10/2013
• 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: 02/19/2019 Patient Sequence Number: 1