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

Model Number 8637-20

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Weakness (2145); Numbness (2415); Sleep Dysfunction (2517); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving intrathecal bupivacaine, unknown baclofen, and unknown morphine (unknown concentrations and doses) via an implanted pump for non-malignant pain and failed back syndrome- other.It was reported the patient thought she was having a failure with her pain pump and the pump was malfunctioning.The patient wanted to know if other patients have had this issue with their pump.It was noted for the last three months, ¿it was getting worse and frequent.¿ the patient could not wake up, got confused and really spacey, and weak.The patient usually slept until 5:00pm each day.It was reported the patient ended up in the emergency room (er) on (b)(6) 2018.It was noted for the first-time last night on (b)(6) 2018, she felt numbness.The patient had scoliosis and problems with her leg (presumably prior to implant), and she felt numbness in her leg and abdomen.The patient would see a pain nurse tomorrow on (b)(6) 2018, and she did not know what was reported to this pain nurse.The patient was redirected to follow up with the healthcare provider (hcp).No further complications were reported/anticipated or expected.

Manufacturer Narrative

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.

Event Description

Additional information was received from a consumer indicated she wanted to have the device removed.It was noted she had fallen, was foggy, and could not think {event date regarding these symptoms was not reported}.Physician listings were requested.No further complications were reported/anticipated or expected.

• 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
• MDR Report Key: 7890591
• MDR Text Key: 122103934
• Report Number: 3004209178-2018-21032
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR