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

Model Number 8637-40

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Date 10/12/2020

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 2000 mcg/ml of baclofen at 987 mcg/day via an implantable pump.It was reported that sometime the week before the patient's pump started alarming, and they had to go from (b)(6) to get their pump refilled because they had missed their refill.The patient went to the emergency room (er) in texas and the er would not give him any medication.The patient reported their pump was since refilled and was no longer alarming.However, the patient stated they were currently experiencing a severe return of symptoms and their legs were so stiff they were unable to move them.The patient could hardly walk or get out of bed.The patient called their doctor, and their doctor told them to contact the manufacturer to obtain a list of doctors in their area.Physician listings were provided.

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 received from a healthcare provider (hcp) indicated that the low reservoir alarm was occurring when the pump was refilled.On (b)(6) 2020 the pump was refilled.The cause of the symptoms following the refill were missed refill appointments on (b)(6) 2020.A prescription was called in for oral baclofen and the patient was scheduled for clinic follow-up.The next pump refill was on (b)(6) 2020.

• 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: 10721935
• MDR Text Key: 213052136
• Report Number: 3004209178-2020-18511
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 95