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

Model Number 8637-40

Device Problems Application Program Problem (2880); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Distress (2329); Malaise (2359); Sweating (2444); Shaking/Tremors (2515)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving an unknown drug (unknown concentration and dose) via an implantable pump for an unknown indication for use.It was reported there was a pump issue.The event date was (b)(6) 2020.The patient experienced pain increase.Catheter opacification was performed, but no problem was identified.A rotor test was performed; it was stated the test showed a problem with the pump, as the rotor did not turn as planned.The pump would be replaced on (b)(6) 2020.The issue was not resolved.It was stated no external factor had contributed to the issue.The patient status was alive - no injury.Further complications were not reported.Additional information was received.No issues were identified in the pump logs.The pump was successfully replaced on (b)(6) 2020 and the event resolved.The pump would be returned.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Pump interrogation at medtronic (b)(4) indicated the pump was delivering morphine 10.0 mg/ml at a dose of 1.998 mg/day.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the pump identified no anomalies.A review of the pump interrogation report indicated the pump had been delivering morphine 10.0 mg/ml at 1.998 mg/day.If information is provided in the future, a supplemental report will be issued.

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 via a foreign user report (that was forwarded to the manufacturer by a foreign agency).It was related that the patient had been using the pump for several years as treatment for chronic benign neuropathic pain.It was detailed that following the last filling on (b)(6) 2019 the patient developed withdrawal syndrome initially of low specificity with repeated consultations in their service where the reading of the system did not find any problems.Then, with exacerbation of chronic pain and tremors with episodes of anguish, sweating, and general malaise, they conducted an x-ray test of the operation of the pump on (b)(6) 2020.Good permeability and thus its functionality of the catheter was found, but on the other hand blockage of the motor of the pump was found.It was described that the withdrawal syndrome was "fairly severe." use of oral morphine improved pain and made the pain go away but the withdrawal symptoms never stopped, per the user report.The pump was replaced on (b)(6) 2020 [as previously re ported].

• 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: 9649564
• MDR Text Key: 185520465
• Report Number: 3004209178-2020-02242
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Date Manufacturer Received: 05/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention