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

Model Number 8637-20

Device Problems Premature Elective Replacement Indicator (1483); Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2021

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 foreign healthcare professional (hcp) via a distributor regarding a patient receiving gabalon 210 mcg/day via an implantable infusion pump with an indication for use of hypoxic encephalopathy.It was reported that at the time of the refill in (b)(6) 2020, the elective replacement indicator (eri) was 7 months.Therefore, the patient was hospitalized from (b)(6) 2021 to replace the pump, but when performing interrogation, the eri became (b)(6) 2021.It was noted that it was unconfirmed whether the alarm was sounding.A refill was performed and it was confirmed that there was no abnormality in the variability.On (b)(6) 2021 the distributor met the attending physician and the logs were checked.After the occurrence of eri, it was confirmed that motor stall occurred and motor stall recovery occurred were repeated 5 times from (b)(6) 2021 to (b)(6) 2021.The pump replacement that was originally scheduled in april was to be performed on (b)(6) 2021 to replace it as soon as possible.It was indicated that the causality of the event was related to the pump.No further patient complications were reported.

Event Description

A session report from an interrogation on (b)(6) 2021 with pump event logs were provided via a request for follow-up.This report showed the drug concentration programmed at the time of the event was 1000 mcg/ml.The report showed the eri and motor stalls as reported as well as a low reservoir alarm, with the following date and time details from the logs: (b)(6) 2021 17:31 (0d) - eri occurred on (b)(6) 2021 01:24 (03) - motor stall occurred on (b)(6) 2021 01:50 (1a)- motor stall recovery occurred on (b)(6) 2021 14:46 (03) - motor stall occurred on (b)(6) 2021 15:32 (1a)- motor stall recovery occurred on (b)(6) 2021 06:40 (03) - motor stall occurred on (b)(6) 2021 06:53 (1a)- motor stall recovery occurred on (b)(6) 2021 07:49 (03) - motor stall occurred on (b)(6) 2021 08:47 (1a)- motor stall recovery occurred (b)(6) 2021 16:13 (03) - motor stall occurred on (b)(6) 2021 16:13 (04) - stopped pump period may exceed tube set (b)(6) 2021 09:46 (1a)- motor stall recovery occurred on (b)(6) 2021 22:32 (1a)- low reservoir alarm occurred additionally, it was confirmed that the replacement was performed on (b)(6) 2021 as scheduled and the pump was being returned.Further information received also noted that after removing the pump, the alarm was heard about once every 5 minutes and the silent the alarm was unable to be programmed.It was also stated that since the pump had a motor stall event it could affect the catheter so the condition of the catheter was requested to be informed just in case.

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.

Manufacturer Narrative

H3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing.Destructive analysis identified electrochemical migration across the electrical feed-through insulator.Medtronic developed a design change to reduce feed-through shorting and received regulatory approval for the change.Medtronic began distributing pumps with this design change in january 2016.H6: annex b updated to b01.Annex c updated to c07.Annex d updated to d01.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: 11507718
• MDR Text Key: 244127064
• Report Number: 3004209178-2021-04456
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2021

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: 11/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 03/19/2021; 05/21/2021
• Supplement Dates FDA Received: 03/24/2021; 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1579-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention