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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

Refer also to mfr report # 3004209178-2017-19310 for prior (2017) event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving compounded baclofen (3000 mcg/ml at 449.7 mcg/day) via an implantable pump.It was reported that the pump was alarming.The patient went to the hospital and the pump was interrogated.It was discovered that the pump had two motor stalls and was now working.The logs noted that a pump refill, infusion prescription change, and patient configuration change occurred on (b)(6) 2021.As per the logs, a motor stall occurred on (b)(6) 2021 at 12:21 followed by a motor stall recovery on (b)(6) 2021 at 13:04.A second motor stall occurred on (b)(6) 2021 at 14:04 followed by motor stall recovery the same day at 14:23.There were no known environmental/external/patient factors that may have led or contributed to the issue.The issue was not resolved as of (b)(6) 2021.The patient was without injury regarding their status as of (b)(6) 2021.No surgical intervention had occurred, and no surgical intervention was planned.The patient's medical history and weight at the time of the event was unknown or would not be made available.

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 from the foreign healthcare provider (hcp) via the manufacturer's representative (rep) on 2021-dec-02.It was reported that there were no known circumstances that might have contributed the patient not having heard a pump alarm for one of the two motor stall as captured in the logs.No further actions were taken to resolve the issue.

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 from a foreign healthcare provider via a company representative.The patient did not have any magnetic resonance imaging (mri) scan or was near any mri scanner.Two motor stalls had occurred, and the patient heard the alarm on only one of the stalls.They were questioning what could potentially cause motor stalls in everyday life.The patient did not have other implanted devices ((i.E., vagus nerve stimulator, pacemaker etc.).Since 2017, the patient had changed their phone case to one without any magnet and did not carry their mobile phone in their jacket next to the pump.It was further noted that the patient did use a separate handbag to put the phone and wallet, and this was kept 6 inches away from the implant site.The patient did not have a hobby in which they could be exposed to magnets or a magnetic field.It was noted that when the motor stalls occurred, the patient was lying in his bed resting his pressure points of the skin/seating area.In his bedroom, there was a tv turned on which was approximately 5 meters away.The patient¿s mobile phone / iphone was on the bedside table about an arm¿s length away.There was a fan and a table lamp in the room which were not switched on at the time of the stalls.It was noted that the patient¿s wife mobile phone (samsung) and cordless charger were in the kitchen approximately 10 meters away.The bed did not have any electronic controls and no other electrical devices were nearby.The patient did not have any underdose symptoms and did not feel anything different.Regarding the baclofen solution in the pump, they had been using the same solution from one supplier for all their patients with the intrathecal baclofen therapy with synchromed ii pumps since 2001 approximately.The specifications, especially the ph and the electrolytes of the baclofen solution, were all in the recommended range.Additional information was received from a healthcare provider via a company representative on 2021-(b)(6).The issue / intermittent motor stalls had not resolved.The healthcare provider did not request analysis.The pump remained still in use and was to be monitored.

Event Description

Additional information was received via a healthcare provider.No further actions had been taken or was planned regarding the intermittent motor stalls, with last stall and recovery having occurred on (b)(6)2022.The patient was being monitored.The cause of the intermittent motor stalls / motor stall on (b)(6)2022 was not determined.The pump remained implanted and in use.

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 from a foreign healthcare provider via a company representative.The company representative was notified that the another critical alarm occurred and it was the same situation, no magnetic fields, etc.As per the pump log provided, a motor stall occurred on 2022-(b)(6) at 19:19 followed by a motor stall recovery the same day at 20:04.It was noted that this patient had a similar episode in (b)(6) 2021.Both incidents he was just lying in the bed with no magnetic gadget around except his iphone.The pump was administering baclofen with concentration 3,000.0 mcg/ml at a dose rate of 449.7 mcg/day.Estimate elective replacement indicator was to occur in 57 months.

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: 12913742
• MDR Text Key: 282507515
• Report Number: 3004209178-2021-17872
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup,Followup,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 11/29/2021; 11/29/2021; 12/02/2021; 02/07/2022; 02/20/2022
• Supplement Dates FDA Received: 12/02/2021; 12/02/2021; 12/03/2021; 02/10/2022; 02/22/2022
• Date Device Manufactured: 11/20/2019
• 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 Age: 34 YR
• Patient Sex: Male