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

Model Number 8637-40

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Overdose (1988); Complaint, Ill-Defined (2331); Low Oxygen Saturation (2477); Cognitive Changes (2551)

Event Date 05/28/2019

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 professional (hcp) via a company representative regarding a patient receiving morphine (24 mg/ml at 6 mg/day), bupivacaine (28 mg/ml at 7 mg/day) and fentanyl (320 mcg/ml at 80 mcg/day) via an implanted pump.It was reported that at the time of the pump refill in (b)(6) 2020, the expected residual volume was 5.3 ml but barely 1 ml was removed.They proceeded with the pump refill using ultrasound.The next day they were notified that the patient was obtunded and had overdose symptoms.The patient subsequently spent 14 days in the icu (intensive care unit).The patient responded to narcan which was eventually weaned.There was no evidence of subcutaneous fluid immediately post refill or when the patient was admitted to the er (emergency room).No it (intrathecal) changes were made.The patient had been doing well since and had good pain control.Today ((b)(6) 2020) the patient came in for a pump refill and the hcp encountered the same scenario.They were expecting 5.8 ml but less than 1 ml was removed.The patient was very happy with the therapy, so the pump was refilled with only 10 ml and they were having the patient come back in 3 weeks for the next refill and to check the residual volume.The next day ((b)(6) 2020) they got a call from the patient¿s wife that the patient was at 90% oxygen; at 1:30 am felt itchy; and by morning his o2 levels would be variable down to the 70¿s and around the lower 80¿s.The patient had great pain control and a lower blood pressure (116/68).He had urination issues, but no discomfort.That afternoon a decision was made to take him to the hospital.The patient was admitted to the er with breathing issues.Per the hcp, the patient had no heating therapies or hyperbaric treatment.They were planning to program the pump to minimum rate.

• 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: 10682941
• MDR Text Key: 211442122
• Report Number: 3004209178-2020-17984
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2020
• Date Device Manufactured: 07/18/2019
• 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: 77 YR