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

Model Number 8637-40

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving fentanyl (450 mcg/ml at 50mcg/day) and bupivacaine (22,500 mcg/ml at 2500 mcg/day) via an implantable pump for spinal pain indications.It was reported that the patient had loss of therapeutic benefit.There were no known factors that may have contributed to the issue.They were unable to aspirate from cap (catheter access port) chamber.They opened the spinal segment pocket on (b)(6) 2022 and replaced the spinal segment.At that point, they were still unable to aspirate from cap.They opened the pump pocket segment and found no noticeable kinks.The pump segment was replaced and attached in the pump pocket site.They were able to aspirate from the cap successfully.The pump was updated with new catheter lengths.The issue was resolved at the time of report.The patient's medical history was asked but unknown.The patient's status at the time of report was alive - no injury.

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2022, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 17-aug-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• 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: 14454986
• MDR Text Key: 292167100
• Report Number: 3004209178-2022-06466
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2022

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: 02/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 05/20/2022
• Date Device Manufactured: 09/04/2020
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 90 KG