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 Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Insufficient Information (4580)

Event Date 04/19/2022

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) via a company representative and a consumer regarding a patient receiving fentanyl, bupivacaine, and clonidine via an implanted pump.The indication for pump use was spinal pain.It was reported that two home health agency nurses completed a pump refill on (b)(6) 2022.Two hours later, the patient started to feel sleepy; had low blood pressure; went to the er (emergency room); got narcan; and threw up.No pocket fill occurred as the nurses checked multiple times as they filled the pump.A home health nurse went to the er and reported that 5 ml was missing from the reservoir.The drug was aspirated from the reservoir and the pump was refilled with saline and a bridge bolus was performed.No issues showed in the pump logs.There were no environmental, external, or patient factors that may have led or contributed to the issue.A dye study was being considered, but there were no plans at this time.The issue was not resolved at the time of the report, and it was indicated that the hcp had no further information to provide regarding the event.Additional information was received from the patient on (b)(6) 2022 who reported that she had been having troubles since tuesday ((b)(6) 2022) and was currently in the icu (intensive care unit) at the hospital.She stated that she had reached out to her pump hcp but hadn¿t heard back yet.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14216815
• MDR Text Key: 290140710
• Report Number: 3004209178-2022-05285
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 04/27/2022
• Date Device Manufactured: 06/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Female