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

Model Number 8637-40

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

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

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 manufacturer's representative regarding a patient who was receiving 10 mg/day of an unknown concentration of dilaudid, 9 mg/day of an unknown concentration of bupivacaine, and 400 mcg/day of an unknown concentration of clonidine via an implantable pump for non-malignant pain.On (b)(6) 2020, it was reported that the patient's pump elective replacement indicator (eri) was (b)(6) 2020.The pump was noted as "stalled/off now or any day".The hcp noted that, since the patient's pump contains clonidine, withdrawals would kill them.Premature battery depletion was alleged with a potential, unconfirmed motor stall.It was unknown what, if any, environmental, external, or patient factors might have led or contributed to the issue.It was unknown what troubleshooting/diagnostics were performed related to this issue.It was unknown what actions/interventions were taken to resolve the issue.Surgical intervention had been planned but had not been scheduled.The issue was not considered resolved at the time of the event.No symptoms were reported.The patient's status was listed as "alive-no injury".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.

Event Description

Additional information was received from the healthcare provider via a device manufacturer representative indicated that when the pump was read there were no active alarms happening at all, the logs didn¿t show any active alarms either.It was reported that a motor stall did not occur but that the elective replacement indicator (eri) occurred earlier than expected.The cause of the premature eri was unknown.The pump was replaced and then discarded.No further complications have bee reported.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 10144663
• MDR Text Key: 194844270
• Report Number: 3004209178-2020-10171
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention