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 Information (3190)

Patient Problems Fatigue (1849); Memory Loss/Impairment (1958); Therapeutic Effects, Unexpected (2099); Weakness (2145); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Weight Changes (2607); Difficulty Chewing (2670)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, information was received from a patient receiving bupivacaine (5 mg, 2 mg/day) and morphine (5 mg, 2 mg/day) via an implantable pump for peripheral neuropathy.It was reported the patient missed a refill appointment, and his pump started alarming.The patient stated they were not able to be seen by their healthcare professional (hcp) due to covid-19 restrictions and he had to "go to the clinic and bang on the door".The patient stated then the hcp refilled his pump and this "saved the day".The patient reported that when his pump alarm went off, he "lost his memory for two days" and had "a ranchy taste in my mouth and i could smell it".The patient stated their medication was the same as was in the pump at the start of the event "last thursday".The patient also took oral oxycodone.The patient stated the oxycodone does not help him, but confirmed the pumpdid help.The patient did not have a managing physician and was provided listings.

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 on 2020-jun-30 the patient¿s pump discharged a rancid fluid and on (b)(6) 2020 the pump alarm went off again.It was noted the doctor did not want to fill his pump.It was reported the patient was in a "fugue" like state, experienced a rancid taste and smell, he had memory loss for 2 days, his alarm was going off every 5 minutes, and was losing weight rapidly.The patient felt like he was going through extreme opiate withdrawal and could not chew so he was drinking a lot of atkins shakes.The patient reported he was "decompensating", was weak, had no energy with a low body mass index (bmi).It was further reported he was 190lbs and still dropping.The patient had difficulty in finding a healthcare provider (hcp) that would work with him and his pump.It was reported it took a while to find the "right cocktail" for his therapy needs.An email was sent to the rep to help locate an hcp for the patient.It was further reported the patient had made a comment about ¿going to sleep¿ and something about ¿pass¿.The patient clarified he was not suicidal and the company representative (rep) had contacted him and gave him the name of a doctor.No further complications were reported.

• 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: 10404725
• MDR Text Key: 202818661
• Report Number: 3004209178-2020-14051
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/20/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR