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

Model Number 8637-40

Device Problem Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2022

Event Type  Injury  

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

Information was received from a foreign healthcare provider via a company representative regarding a patient who was receiving fentanyl (concentration: 3750.0 mcg/ml, dose rate: at 3256.2 mcg/day) and bupivacaine (concentration: 4 mg/ml, dose rate: 3.4733 mg/day) via an implantable pump for unknown indications for use.It was reported that the patient was hearing some alarms.The surgeon informed that they were getting alarms of short motor blocks (motor stalls) approximately twice a week that could not be referred to external manipulations.Regarding factors that may have led or contributed to the issue, it was further indicated that there were no external factors like magnetic resonance imaging or electromagnetic interference.Telemetry of the pump and reading the protocols was performed.As per the logs the following occurred: (b)(6) 2022 11:59 critical alarm - motor stall, (b)(6) 2022 12:20 motor stall recovery, (b)(6) 2022 21:30 critical alarm - motor stall, (b)(6) 2022 21:35 motor stall recovery, (b)(6) 2022 01:16 critical alarm - motor stall, (b)(6) 2022 01:16 motor stall recovery, (b)(6) 2022 19:36 critical alarm - motor stall, (b)(6) 2022 19:49 motor stall recovery, (b)(6) 2022 03:55 critical alarm - motor stall, (b)(6) 2022 04:02 motor stall recovery, (b)(6) 2022 00:58 critical alarm - motor stall, (b)(6) 2022 01:11 motor stall recovery, (b)(6) 2022 17:43 critical alarm - motor stall, (b)(6) 2022 17:56 motor stall recovery, (b)(6) 2022 19:38 critical alarm - motor stall, (b)(6) 2022 19:45 motor stall recovery, (b)(6) 2022 02:09 critical alarm - motor stall, (b)(6) 2022 02:16 motor stall recovery, (b)(6) 2022 15:04 critical alarm - motor stall, (b)(6) 2022 15:19 motor stall recovery, (b)(6) 2022 16:07 critical alarm - motor stall, (b)(6) 2022 16:22 motor stall recovery, (b)(6) 2022 00:16 critical alarm - motor stall, (b)(6) 2022 00:25 motor stall recovery, (b)(6) 2022 03:27 critical alarm - motor stall, (b)(6) 2022 03:46 motor stall recovery, (b)(6) 2022 01:12 critical alarm - motor stall, (b)(6) 2022 01:19 motor stall recovery, (b)(6) 2022 19:07 critical alarm - motor stall, and (b)(6) 2022 19:12 motor stall recovery.There were no known issues with the catheter.Nothing had been done with the catheter.The patient was doing well.There was no worsening of the patient's general condition or worsening of the pain conditions recognized or had otherwise been described.Pump explant/replacement was planned to occur on (b)(6) 2022.The pump was to be returned for analysis.The issue was not resolved as of (b)(6) 2022.The patient was without injury regarding their status as of (b)(6) 2022.The date (b)(6) 2018 is considered an approximate date of pump implant (specific month and year known only).The patient's medical history and weight at the time of the event was unknown or would not be made available.

Manufacturer Narrative

H3: the pump was returned and analysis found a hole in the internal pump tube which allowed drug to leak into the motor containment area and the fluid/crystallized residue on the feedthru posts which leads to an electrically conductive pathway in and around the pump motor circuit and is consistent with an electrical short 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: 15042146
• MDR Text Key: 296065410
• Report Number: 3004209178-2022-09085
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male