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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider via manufacture representative regarding a patient receiving unknown drug via an implanted infusion pump.It was reported the patient's pump did not recover after waiting 2 hours after the mri.The caller stated the patient had since gone home and the office was closed.Tech services recommended having the patient follow-up with the physician on monday.It was noted the pump was at minimum rate mode.No symptoms were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received via pump session reports.Review of the reports determined that the motor stall event no longer appeared in the logs because the pump had been updated multiple times.The logs, by design, have a 30 entry capacity so the motor stall entry had dropped off as would be expected.There was no issue with regards to the logs.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received via the pump logs.The pump logs dated (b)(6) 2020 showed a motor stall occurred on (b)(6) 2020 at 12:08 pm.The pump logs dated (b)(6) 2020 showed the pump motor stall recovery on (b)(6) 2020 at 3:26 am.The last entry showing on the logs was dated (b)(6) 2020 at 1:39 pm which was after the stall that occurred at 12:08 pm.The pump was delivering fentanyl (8,000 mcg/ml at 50 mcg/day), hydromorphone (6 mg/ml at 0.0375 mg/day) and bupivacaine (15 mg/ml at 0.094 mg/day) at the time of the event.No further complications have been reported as a result of this event.

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 on 09-may-2020 that reported they interrogated the pump today and motor stall recovery had occurred but there was nothing in the logs that the motor stall had occurred.Per the reporter the motor stall was in the logs at one point when they interrogated the pump yesterday but then when they interrogated that pump later in the day yesterday, it was not there as well.There were logs in there from prior to yesterday.Additional information received on 11-may-2020 from the company representative and the healthcare provider who reported that the actions and interventions taken to resolve the motor stall were multiple readings of the pump/logs and calls to the manufacturer.The motor stall had been resolved.No further complications were reported or anticipated regarding the event.

• 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: 10042762
• MDR Text Key: 190541092
• Report Number: 3004209178-2020-08364
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR