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

Model Number 8637-40

Device Problems Filling Problem (1233); Improper or Incorrect Procedure or Method (2017)

Patient Problems Overdose (1988); Therapeutic Response, Decreased (2271)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient who was currently receiving baclofen with concentration 2000 mcg/ml at an unknown dose rate via an implantable pump for intractable spasticity.It was reported that the a physician performed the patient's last pump refill on (b)(6) 2020.Where they switched the patient from baclofen with concentration 500 mcg/ml at a dose rate of approximately 300 mcg/day" to baclofen with a concentration of 2000 mcg/ml of an unknown dose rate.The physician told the company representative on (b)(6) 2020 that the refill on (b)(6) 2020 was a difficult refill and he had to stick the patient 3 times because the patient¿s pump was deep.It was indicated that the physician had also noted that there could have been a pocket fill because the patient came in for a dose titration on (b)(6) 2020 and told them that they had good relief for 3 to 4 days" after (b)(6) 2002, but then the therapeutic affect left.It was being considered that this was likely cause the patient was getting the medication subcutaneously and for 3 to 4 days finally had relief.The patient came in for their refill on (b)(6) 2020 and an alternate physician took over the patient's care.The physician expected 30 cc from the reservoir and did not pull any drug from the patient's pump and there was no empty alarm that occurred, further confirming the likelihood of a pocket fill from (b)(6) 2020.Due to the prior therapy concerns and a pocket fill from (b)(6) 2020, the physician was going to start the patient on 96 mcg/day on (b)(6) 2020 at the 2000 mcg/ml concentration of baclofen and proceed with a dye study and checking the pump logs.The company representative was not with patient for live troubleshooting at the time of the event.The patient¿s weight was noted as having been unknown.No further patient complications have been reported as a result of this event.

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.

Event Description

Doctor is admitting that pocket fill is likely.Dye study will be scheduled.

• 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: 10824046
• MDR Text Key: 216833020
• Report Number: 3004209178-2020-19769
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR