MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182)

Patient Problem Malaise (2359)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a patient receiving an unknown drug via an implantable infusion pump.The indication for use was non-malignant pain.It was reported that the patient was dismissed by the managing healthcare provider (hcp) due to missed appointments.The caller stated that the pump ran out of drugs a couple months ago and the pump was alarming.It was noted that the patient got sick when the drug ran out and that the alarm was getting faint.No further complications have been reported as a result of this event.

Event Description

Additional information was received from a consumer on (b)(6) 2020.It was reported that nothing had been done yet to resolve the issue, the patient was waiting for a removal surgery to be scheduled.The issue was not resolved.The patient's weight was provided.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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 9530239
• MDR Text Key: 173252786
• Report Number: 3007566237-2019-02621
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 95