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

Model Number 8637-20

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Nausea (1970); Dizziness (2194); Loss of consciousness (2418); Confusion/ Disorientation (2553)

Event Date 12/10/2021

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving morphine drug, unknown (13mg/ml at not currently available (may require follow-up)) via an implantable pump for spinal pain.It was reported that during normal pump refill appointment, healthcare provider (hcp) took out 6ccs of drug consistent with what programmer reported as residual.Hcp then injected 20ml pulling back to confirm clear liquid after every 5ccs pushed.As part of diagnostic, after fill hcp confirmed with ultrasound.Patient per protocol stayed 20 minutes started feeling super drowsy, passed out then was hit with narcan and patient came  to hcp then aspirated from the pump and only 17 ccs came out.It was roughly 40mg of morphine injected subdue.  the pump will be replaced on (b)(6) 2021.The issue was resolved at the time of this report.The patient status at time of report was alive no injury.Additional information received form the company representative stated that hcp believed the issue was a pump leak and not a pocket fill.Additional information stated received from the company representative stated that the patient was receiving morphine ( concentration: 13.0mg/ml and dose: 2.354 mg/day), bupivacaine (concentration: 7.8 mg/ml and dose: 1.4124 mg/day), clonidine (concentration: 175.0 mcg/ml and dose: 31.69 mcg/day), and loiresal (concentration : 125.0 mcg/ml and doe: 22.63 mcg/day).

Manufacturer Narrative

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

Manufacturer Narrative

H3: analysis of pump (s/n (b)(6) identified electrochemical migration across the electrical feed-through insulator.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

Information was received from a patient who was receiving unknown drug via an implantable pump for unknown indications for use.It was reported that the patient wanted to talk to someone about a failure of a medtronic pain pump.No other information was provided.Additional information received from a consumer reported the patient's intrathecal pump fill initially proceeded without difficulty under ultra sound (us) guidance.During the fill, there was no abnormality that would indicate any pocket fill or other concern.However, 5-10 minutes post-fill, the patient began feeling lightheaded and dizzy and began having trouble staying awake.Airway remained patent.The hcp performed a repeat us over the pump and did not visualize any significant fluid.The hcp then re-entered the pump and aspirated the contents of the pump and was only able to aspirate - 17cc of the 20cc of fluid that was instilled into the pump.Given that the patient had a higher concentration of hydromorphone in their pump (13mg/ml), -39mg of hydromorphone was unable to be aspirated from the pump and likely was in the surrounding tissue.Given this higher dose of opiate in the patient's tissue, they were given 2 doses of narcan in the office 0.4mg iv which reversed their sleepiness/fatigue/nausea.Ems had been called to transport the patient to north suburban medical center for a likely icu admission and overnight stay to ensure patient airway.The hcp called the hospital er department to give them a verbal overview of the case.In reviewing the case, there were no inherent concerns during the fill.Each sec of medication pushed into the pump was followed by aspiration of 2-3 cc of clear liquid, ensuring that the needle was in the port of the pump at all times.In addition, us was utilized which did not reveal any issue.After speaking to the medtronic representative, what the hcp suspect occurred was likely a failure of the silicone port due to overuse as the patients pump was past its eri (the patient was referred -6 months ago for pump replacement but unfortunately had to delay due to other surgeries.Accordingly, likely 3cc of fluid escaped into the surrounding tissues due to this failure.

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.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13108638
• MDR Text Key: 282905239
• Report Number: 3004209178-2021-19073
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 68 KG