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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/12/2023

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving compounded baclofen with concentration 3000 mcg/ml at a dose rate of 145 mcg/day via an implantable pump.It was reported that the patient received a new pump on (b)(6) 2023 for replacement of their old pump.The patient had experienced dropout symptoms twice before the pump replacement which had occurred a few months ago and resolved within approximately 4 days.It was not known if something changed before the symptoms appeared, such as refill, change in drug dosage or if any volume discrepancy was seen.At the time of pump replacement on (b)(6) 2023, they checked the catheter via the catheter access port (cap).No issue was experienced when aspirating the catheter.They were able to aspirate liquor via the (cap).They replaced the catheter and it seemed that the catheter was changed position a little bit.It was further noted that a 2 cm portion of the spinal catheter was removed and they reconnected at the pump replacement performed on (b)(6) 2023.After the pump replacement, they programmed a lower daily dose of baclofen for the patient then before.Following pump replacement, the patient was again experiencing dropout symptoms, and sometimes some spasm symptoms had returned.Additionally, it was indicated that it seems that the patient sometimes showed overdose and sometimes underdose symptoms.It was further reported that the patient was admitted to the hospital with paralyzed legs on (b)(6) 2023.Magn etic resonance imaging (mri) was performed on (b)(6) 2023 to investigate the cause of these symptoms, and if they might be related to the infusion system or not.However, the mri results were not yet available.They were unsure if the paralyzed legs had been caused by the previous pump replacement.There were no known factors that may have led or contributed to the issue.The issue was not resolved as of (b)(6) 2023.No surgical intervention occurred and it was unknown if surgical intervention was planned.After the mri scan, they interrogated the pump and a motor stall was recorded.However, the motor stall recovery was not yet recorded in the logs.It was being considered that it was possible that there is a delay in logging the motor stall recovery after an mri scan, and the potential for a delay of up to 24 hours to return to proper drug infusion after completion of an mri scan.It was advised to wait some time and then try to interrogate the pump again.They were going to interrogate the pump again on (b)(6) 2023 to check if the motor stall recovery had occurred in the logs.The patient's medical history, age, and weight at the time of the event was unknown or would not be made available.Additional information was received from a foreign healthcare provider via a company representative on (b)(6) 2023.The serial number of the model 8637-20 pump implanted on (b)(6) 2023 was (b)(4).Results of the mri performed revealed no abnormalities; no deviations were seen.The cause of the patient having again experienced dropout symptoms / paralyzed legs, spasms, overdose symptoms, and underdose symptoms following pump replacement and catheter revision on (b)(6) 2023was not determined.It was further noted that the neurologist could not explain why this kept happening and thought it has to do with the progression of the patient¿s illness which was hereditary spasticparaplegia (hsp).Following the mri, the pump motor stall recovered.The duration of the motor stall was more than 2.5 hours.The pump logs were not available.The timing of the motor stall recovery did not coincide with telemetry / interrogation of the pump having been performed; pump interrogation had been performed the next morning.Regarding further actions taken or planed, it was indicated that the pump and catheter will remain in the patient and no replacement of the catheter was scheduled as the neurologist thinks it (dropout symptoms / paralyzed legs) has to do with the patient¿s disease (hsp).The patient having been admitted, spasms, sometimes having showed overdose symptoms and sometimes underdose symptoms had been resolved when the company representative spoke with the neurologist on (b)(6) 2023.It was further noted that the paralysis was mostly gone.The pump dose was reduced to 145 mcg/day.The neurologist was to stop the pump for less than 48 hours to see if and what changes would occur in the patient.

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.At the time of the replacement on (b)(6) 2023, the pump administered compounded baclofen at a dose rate of (b)(4) mcg/day.After the replacement, the dose rate was set to approximately (b)(4) mcg/day.The pump dose rate was now at (b)(4) mcg/day.It was indicated that the company representative had contacted the physician on (b)(6) 2023, and the dropout symptoms were starting to get less.It was further noted that the patient¿s paralyzation had ended on its own after 3 to 7 days, and the neurologist would like to know if there had been any other cases of other patients with a baclofen pump having experienced paralyzation in the legs.The healthcare provider had stopped the pump on (b)(6) 2023 for a couple of hours.The pump had been restarted the same day.It was noted that oddly, the effects were opposite from what the neurologist expected as the patient¿s spasticity became less and the paralyzation was more following the pump having been stopped temporarily.The neurologist had no explanation of why this had happened.The pump was currently working and the dose rate was (b)(4) mcg/day again.No further action was planned.Refer also to mfr report # 2182207-2023-00952 regarding prior event.

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: 17005691
• MDR Text Key: 315992432
• Report Number: 3004209178-2023-07109
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• Date Device Manufactured: 03/27/2023
• 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): Other
• Patient Sex: Male