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

Model Number 8637-40

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Muscle Spasm(s) (1966); Seizures (2063); Therapeutic Response, Decreased (2271); Coma (2417); Loss of consciousness (2418); Decreased Respiratory Rate (2485); Cognitive Changes (2551)

Event Date 05/11/2020

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 (rep) regarding a patient receiving intrathecal gablofen 2000 mcg/ml at 899.2 mcg/day via an implanted pump.It was reported the event/difficulty occurred on (b)(6) 2020 during normal use.It was reported the patient was admitted to the neuro intensive care unit (icu) on (b)(6) 2020 for seizures and loss of consciousness and was intubated.It was noted the rep had talked to the patient¿s mother and care giver and they reported in the last two weeks the patient had more spasms in her legs.They called the doctor and he had ordered oral baclofen 40 mg four times a day for withdrawal symptoms last week, but the spasms continued.The pump was interrogated, and logs were read.There were no motor stalls or malfunctions of the pump.No other interventions were taken at this time.The issue was not resolved at the time of this report and the patient¿s status was ¿alive- no injury.¿ it was unknown if surgical intervention was planned and asked but would not be made available (legal/confidential reason).It was further reported the patient had a medical history of seizures and the patient¿s weight was unknown (asked and would not be made available (legal/confidential reason)).Additional information was received from a healthcare provider on the same day indicated the patient was in the emergency room with "potential seizure like activity, glasgow coma scale of 3, decreased respiratory saturation, hypotension, and altered mental status." it was noted they placed the patient on oxygen to help with the decreased respiratory saturation.It was also reported the patient was prescribed oral baclofen (date asked, unknown) as reported above because they thought that the pump may not have been working.The reporter wanted to get in contact with managing physician of the pump first and provided the reporter with national answering service (nas) contact information to have a rep come to facility to interrogate the pump if the managing physician could not.No further complications were reported.Additional information was received from a rep on 2020-may-13 indicated the patient was having an increase in spasms and seizures.The pump was interrogated and logs were read.It was noted the patient had a history of cerebral palsy and history of seizures.The cause of the event was unknown at time and the rep was only asked to interrogate the pump and read the logs.No additional actions were taken.It was also unknown if the event was resolved.The event was noted as a ¿therapy issue¿.The pump was still implanted and would not be returned for analysis at this time.No further complications were reported.

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 health care professional via a company representative on (b)(6).It was reported that the patient was seen on (b)(6) for her pump refill appointment.According to the family the patient had been receiving oral baclofen 40mg three times daily prior to her hospitalization for her spasms, per the doctor's instructions.The patient sister stated that the hospital called the issue a baclofen overdose due to the oral baclofen taken in the days prior to the hospitalization.Her intrathecal dose was approximately 900 mcg/day along with the oral medication.She was doing much better and had no spasms to report on the date of the refill.She was awake and not sleepy.She had stopped the oral baclofen and was only on intrathecal therapy.She had been discharged from the hospital on (b)(6).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: 10111200
• MDR Text Key: 193425601
• Report Number: 3004209178-2020-09563
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: 06/04/2020

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: 10/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR