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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Apnea (1720); Itching Sensation (1943); Overdose (1988); Seizures (2063); Loss of consciousness (2418); Sleep Dysfunction (2517); No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product(s): product id: neu_label_acc, lot#/serial# unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (patient¿s mother) regarding a patient who was receiving lioresal of an unknown concentration at a dose rate of 1100 mcg/day via an implantable pump for intractable spasticity.The lioresal dose rate was noted as having been decreased later to an unspecified dose rate.It was reported that the patient became unconscious and then stopped breathing.The patient did not react to noxious stimuli either.They originally thought the patient sleeping a lot and that it was due to possible social changes/situations, but when the patient would not wake up and their face itched they called 911.The date of the event was (b)(6) 2019.The monday before the incident ((b)(6) 2019) a pump refill occurred, and the dose was increased 5-10%.The staff was going to intubate the patient and the patient did receive dopamine.The healthcare provider (hcp) thought the patient maybe had a seizure.It was noted that no eeg was done until after the patient was discharged from the hospital and they felt that was also wrong because of the seizure suspicion.It was noted that the staff needed to call the physician and they did not listen to them stating they had to stabilize the patient.The emergency department (ed) did not immediately call the pump follow-up physician or the manufacturer despite them telling the ed staff they needed to do that.It was noted that the ed staff pushed narcan and did not follow the protocol for intrathecal baclofen (itb) emergency procedures.It was stated that the manufacturer has a responsibility to supply physician programmers to the hospital and that all hospitals ed staff be trained or have regular in-services for itb emergency procedures.They were questioning whether the manufacturer trains ed staff and why the staff does not have a physician programmer device available to utilize.The consumer did not think there was any protocol in place for itb emergency procedures and was upset about that and legal action was being considered.Pertinent information was reviewed at the time of the report regarding the consumer¿s inquires.The itb representative was also emailed requesting a call back to the consumer to answer their questions regarding itb emergency procedures and in-service trainings and supplying physician programmers to ed staff.It was further reported that they needed a new current manufacturer patient identification (id) card.It was indicated that the old one was printed and sent 7 months after the second pump was implanted.It was indicated that there was a wrong name on the card and that the physician¿s name was on the back instead of the front of the patient id card.The date (b)(6) 2019 is considered an approximate date of event (year known only) regarding the issue with the id card.It was also indicated that the patient had a rash with margins that had nothing to do with the pump/therapy and was diagnosed with atypical melanoma when a biopsy was done.They had got a second opinion from another physician.That physician had made a large incision / performed surgery for the melanoma on the patient¿s left abdomen area and leg.No further patient complications have been reported as a result of this event.

Event Description

Additional information was received from an hcp on (b)(6) 2019.It was reported that there was no device issue or patient/therapy issue or procedure issue related to the patient unconsciousness, lack of breathing, itching face, and administration of narcan.It was noted that the dose had only been increased 5% and pump interrogation was unremarkable.It was indicated that the seizure activity was not confirmed and it was further stated that there were no device or therapy issues.Diagnostics/troubleshooting included supportive measures, intravenous (iv) fluids, dopamine, icu monitoring, and a 2-5% dose reduction.The cause of the symptoms was not determined and the patient returned to baseline after the above measures.The patient also underwent a three day electroencephalogram (eeg) and repeatedly no seizures were seen.The issue was considered resolved and the device was working well.The pump was refilled on (b)(6) 2019 and the dose was increased 2.5% from 1100.9 to 1129mcg/day.

Manufacturer Narrative

H6: the previously reported patient codes and evaluation conclusion, method, and result codes no longer apply.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
• MDR Report Key: 9427744
• MDR Text Key: 169732752
• Report Number: 3004209178-2019-23262
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: 01/03/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE B5
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 13 YR