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

Model Number 8637-40

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)

Patient Problems Fall (1848); Muscle Weakness (1967); Ambulation Difficulties (2544); Convulsion/Seizure (4406); Cramp(s) /Muscle Spasm(s) (4521); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider regarding a patient receiving gablofen (2000 mcg/ml at 1151 mcg/day) via an implanted infusion pump.The indication for use was intractable spasticity and head/brain injury.It was reported the patient had a pump refill and there were expecting to get 9ml in the pump.It was noted the hcp barely pulled out 1 ml from a 20 ml pump.The hcp was going to check the volume again in 1-2 weeks ago.The hcp didn't think it was a pocket fillor programming error.

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 by a healthcare provider (hcp) who reported that the patient had a refill on (b)(6) 2021, and there was a volume discrepancy in the reservoir.They expected 7 ml in the pump but aspirated 0 ml.It was noted that they pulled back and got bubbles.They filled the pump and were able to fill with the full 40 ml.The hcp stated considering overinfusion or error at the last refill for the discrepancy in volume.Additional information was received by a healthcare provider (hcp) via company representative (rep) who reported that the patient had their pump replaced on (b)(6) 2021.There were no external factors that may have led or contributed to the issue.It was reported that the issue was resolved at the time of report.The patient's weight and medical history were asked but unknown.The patient's status at the time of report was alive - no injury.

Manufacturer Narrative

H3: the returned device passed all testing in the laboratory and no anomalies were identified.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 received from the healthcare provider reported that the patient was seen on (b)(6), 2021 for a normal refill, expected volume was 10.1, volume aspirated was 11.5.This refill and all refills for this patient were done with 2000 mcg gablofen.Per the healthcare provider the next time the patient was seen their practice was (b)(6), 2021, he had had a recent seizure and fall on (b)(6) 2021.He was hospitalized at yale new haven.An mri was done.The patient had recently started ritalin and the seizure was attributed to this.When the pump was accessed to be aspirated, we had 0 ml available to be aspirated.3 different needles were utilized with no change in results.Ultrasound is always used for guidance.They were able to fill the pump with the full 40 ml gabapentin, indicating that the pump had run dry.Per the healthcare provider the patient had an episode of generalized weakness on (b)(6) from a different outside hospital.The patient presented to the emergency department from home with complaints of frequent urination, frequent dry mouth, and increasing weakness with frequent falls over the last 1 week.The patient¿s mother states over the past 1 week she has noted patient having a progressive weakness.Patient reports feeling his whole body is weak.He denies any focal weakness to his arms or legs.He also reports having a dry mouth that feels burning and irritated.Mother states the patient has been drinking lots of fluids and has been having a normal appetite.She also states that he has been urinating very frequently.Mother states yesterday she started testing the patient's urine for ketones and noticed that there was ketones in his urine.She states that throughout the week his blood sugars have been below 200 and he has been adjusting his insulin accordingly.Patient denies any fevers or chills.No cough, nasal congestion, or sore throat.Patient has received the covid-19 vaccination.He denies any shortness of breath or difficulty breathing.No abdominal pain, nausea, vomiting.Patient does have typically constipation however did report one episode of diarrhea today.Denies any blood noted to his stool.Denies any chest pain.He does report having frequent falls over the last 24 hours.Patient states that he feels that he is losing his balance when he is ambulating.He denies any lightheadedness or dizziness prior to the events.He denies any chest pain or shortness of breath prior to the falls.Patient states that he has hit his back as well as his knee during the incidents but have not hit his head or lost any consciousness.No blurry vision or double vision.He denies any urinary symptoms such as urgency or dysuria but does report frequency.Patient has received the covid-19 vaccination.The physician made a decision on (b)(6)-2021 that the pump had over infused causing generalized weakness and then under-infused causing seizure and spasms.They checked the dates to see if it was possible that we had not put in the full 40 ml volume at the june visit, however both myself and my nurse documented we had.The timing of a possible under-fill at the june visit was checked and didn't correspond with the dates.

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: 12309202
• MDR Text Key: 266087056
• Report Number: 3004209178-2021-12264
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2020
• 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; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male