MAUDE Adverse Event Report: MEDTRONIC 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 Low Blood Pressure/ Hypotension (1914); Overdose (1988); Lethargy (2560)

Event Date 08/28/2018

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) regarding a patient who was receiving fentanyl (2050 mcg/ml at 49. 97 mcg/day), baclofen (1200 mcg/ml at 648 mcg/day), and morphine (5 mg/ml at 2. 725 mg/day) via intrathecal drug delivery pump. The indication for use was noted as intractable spasticity and cerebral palsy. It was reported that the patient was relaxed, hypotensive, and lethargic. The patient was receiving narcan. The pump was programmed to minimum rate. The patient started having symptoms the night of (b)(6) 2018. Interrogation confirmed that the patient was still getting the bridge bolus. The patient had a refill on (b)(6) 2018 where the hcp switched medications from baclofen and morphine to fentanyl. There were no further complications reported at this time.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer via a manufacturer representative. It was reported that the patient was fine as of (b)(6) 2018 and they did not think this was a pump issue. While the patient was in the emergency room (er), the narcan did not help. There were no further complications reported at this time.

• 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: 7839219
• MDR Text Key: 118963876
• Report Number: 3004209178-2018-19726
• 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,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/28/2017
• 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: 09/07/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/29/2015
• 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: 08/31/2018 Patient Sequence Number: 1