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

Model Number 8637-20

Device Problems Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 2020-sep-09, information was received from a patient receiving baclofen (unknown dose and concentration) via an implantable pump.The patient's healthcare professional (hcp) was no longer practicing and they have been looking for a new hcp to fill.The patient has not been successful finding a new hcp that services pumps.The patient was past their alarm date, which was scheduled to alarm (b)(6) 2020.The pump has been alarming a single beep, but as of yesterday, pump now had dual tone alarm.The patient went to the emergency room (er), but they were only given oral baclofen (10 mg, 3x/day).No symptoms or patient complications reported.Physician listings were provided to the patient.

Event Description

Additional information was received from a healthcare provider who reported that an empty reservoir occurred on (b)(6) 2020 that was confirmed via the event logs.The patient had switched follow up physician¿s and was just seen today by their new follow up physician.Per the reporter, the pump went empty in between switching physicians.The new physician also changed the drug/concentration to 600mcg/ml and decrease the daily dose to 50mcg/day.Troubleshooting options were reviewed and the issue was not resolved through troubleshooting.The reporter would confer with the physician and the patient.The patient was receiving compounded baclofen 50mcg/ml and lioresal 2000mcg/ml at 270mcg/day.

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.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
• MDR Report Key: 10515810
• MDR Text Key: 209140993
• Report Number: 3004209178-2020-15709
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR