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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problems Nausea (1970); Pain (1994)

Event Date 03/24/2023

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving dilaudid/hydromorphone (25 mg/ml at 4 mg/day) via an implanted pump.The patient¿s medical history was chronic pain.The indication for pump use was failed back surgery syndrome and non-malignant pain.It was reported that the patient had a pump replacement about 2-3 weeks ago and stated that things were fine for a while.Then had 5 days of severe pain/lack of effectfrom the pain pump and nausea.The patient was admitted to the hospital for several days.X-rays were normal.The patient was then taken to the or (operating room) for exploration.Cap (catheter access port) aspiration revealed ability to empty the catheter of drug, but there was very poor csf (cerebrospinal fluid) flow.A dye study revealed the appearance of a leak in the spinal area.The catheter was removed and there were no obvious issues.On testing after removal, a leak was noted 2-4 cm from the anchor and a fracture of the catheter was obvious.Foreign material in the end of the catheter was also noted.The environmental, external, or patient factor that may have led or contributed to the issue was noted to be ¿recent pump replacement¿.Following the procedure, the patient¿s pump dose was decreased from 4 mg/day to 1.2 mg/day.

Manufacturer Narrative

Concomitant medical products: product id 8709 lot# serial# (b)(4) implanted: (b)(6) 2004 explanted: (b)(6) 2023 product type catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 07-oct-2005, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 16681414
• MDR Text Key: 312685534
• Report Number: 3004209178-2023-04554
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422615
• UDI-Public: 00763000422615
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2023
• 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: 03/29/2023
• Date Device Manufactured: 03/22/2022
• 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; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male