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

Model Number 8637-20

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964); Patient Device Interaction Problem (4001)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 12/10/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 13-jul-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) and a consumer via a company representative regarding a patient receiving fentanyl (500 mcg/ml at 24.03mcg/day), bupivacaine (20 mg/ml at.961 mg/day), and clonidine (300 mcg/ml at 14.42 mcg/day) via an implanted pump.It was reported that the patient was having inadequate pain control.The patient stated that he felt that the pump was at times "ineffective¿.This prompted the hcp to do a dye study during which he was unsuccessful in aspirating from the catheter.The pump logs were also reviewed.The plan was then for the patient to be taken to surgery to open the pocket and ascertain what needed to be done to revise or correct the issue.The patient was taken to surgery.The pocket was opened, and the hcp attempted to aspirate from the cap (catheter access port) and at first, he was unsuccessful.Ultimately, he disconnected the catheter from the pump and found some biological debris (unknown tissue) surrounding the pump connector.He removed the debris; the catheter flowed freely; and he was then able to aspirate from the catheter.He aspirated 2 cc of drug from the catheter and proceeded with injecting contrast dye and followed it to the intrathecal space in the spine.The incision was then closed, and the pump was primed appropriately in the recovery area.There were no environmental, external, or patient factors that may have led or contributed to the issue.The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.

• 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: 13010518
• MDR Text Key: 282273529
• Report Number: 3004209178-2021-18569
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Date Device Manufactured: 07/17/2019
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male