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

Model Number 8637-20

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Cyanosis (1798); Dyspnea (1816); Fatigue (1849)

Event Date 05/05/2021

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 health care professional (hcp) via a device manufacturer representative regarding a patient receiving dilaudid (8000 mcg/ml at 3000 mcg/day) via an implantable infusion pump. It was reported that the patient came in for a refill on (b)(6) 2021. Later that day, they experienced drowsiness, labored breathing and cyanotic skin color. They were admitted to the intensive care unit (icu) and given narcan. They withdrew the medication from the pump and got 18mls, but expected 20mls. The doctor suspected overdose and subsequently decreased the infusion rate on (b)(6) 2021. The patient's pain control was not adequate after reducing the infusion rate, so he was prescribed oral supplemental opioids on (b)(6) 2021. The hcp made the decision to replace the pump due to suspected overinfusion. Upon explant, 6. 5mls were expected but the actual residual volume was 3. 5mls. The backflow of cerebrospinal fluid was sluggish. A back table prime was conducted on the new pump prior to attaching to the existing catheter, and infusion was started at 2550 mcg/day without priming the catheter. The issue was considered resolved. The patient's status at the time of the report was alive - no injury. 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11791399
• MDR Text Key: 249507221
• Report Number: 3004209178-2021-07384
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2018
• 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: 05/07/2021 Patient Sequence Number: 1