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

Model Number 8637-20

Device Problems No Audible Alarm (1019); Pumping Stopped (1503)

Patient Problem Pain (1994)

Event Date 04/01/2022

Event Type  Injury  

Event Description

Information was received from a consumer via a manufacturer representative regarding a patient who was receiving morphine via an implantable pump for spinal pain.It was reported that the patient stated they woke up today in "so much pain".The personal therapy manager (ptm) indicated a 8476 motor stall alert on (b)(6) 2022 at 15:45.They did not hear an audible alarm coming from the pump but were having severe pain.Agent reviewed meaning of the code screen, reviewed mdt role and redirected to healthcare provider (hcp).The patient stated their hcp was closing for the weekend.Agent reviewed considerations and sent hcp listing per patient's request.The patient stated they would contact 911.The company representative (rep) later reported that when the patient said their pump was not working when they went to give themselves a bolus and that patient services told them that the pump had stopped.It was unknown if any environmental factors contributed to the event.The patient¿s elective replacement indicator (eri) is in (b)(6) 2022. no diagnostics or troubleshooting were performed other than reading logs and confirming through logs patient¿s pump has stalled.At the moment there may be a replacement but the rep was not sure as of yet.Surgical intervention did not occur and it was not planned.The ev ent was resolved at the time of the report.

Manufacturer Narrative

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

Event Description

2022-04-07 e1 (rep) additional information was received that the patient was scheduled to have replacement on (b)(6) 2022.

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.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14023021
• MDR Text Key: 288815966
• Report Number: 3004209178-2022-04328
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2022
• Date Device Manufactured: 08/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male