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

Model Number 8637-40

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Hematoma (1884); Hemorrhage/Bleeding (1888); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/20/2021

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 company representative (rep) via a consumer's representative (con) regarding a patient with an implantable infusion pump receiving baclofen (unknown) with a concentration of 500 mcg/ml and a dose of 103.7 mcg/day for intractable spasticity.It was reported that the patient recently had their pump replaced and during the surgery , the surgeon and the assisting resident had accidentally cut something and caused a hematoma.It was reported that the assisting resident said "i could have hit the vein but i didn't".It was reported that the surgeon told them that the body will take care of it and to not worry about it since it is not life threatening.It was reported initially when the patient came out, their bandages over the incision site was saturated with blood so patient's representative knew something was not right.It was reported the patient's body was now black and blue all over the body from the blood moving and the hematoma is in the abdomen area.It was reported the hematoma was the size of a small cantaloupe.It was reported it was also very swollen over the pump site.It was reported that patient's representative wanted to know if there will be any issues with the pump.They confirmed that the patient's spasticity hasn't been an issue but wanted confirmation.Patient services reviewed if the pump and catheter are fine then there shouldn't be any issues and redirected to hcp (health care provider).It was confirmed the next refill date is on 3/7 and they are also seeing the surgeon again this friday.Troubleshooting was not required.Additional information received from the patient stated patient had issues with severe spasticity since around january.Patient will have bad cramping at night, but no fever or pain and no other health issues.Patient repeatedly stated the patient was very sensitive to the medication.Patient apparently started to feel changes before the next refill so they usually go in to have the pump filled sooner.At the last refill the pump had gotten lower than they normally let it go but it wasn't low or empty.Patient mentioned they increased the medication and the diagnostics and xray had shown everything looked fine so far.Patient stated the increase in medication has not made a difference in the symptoms.Patient inquired about model of pump and recalls.Patient was redirected to the provider.Additional information received from the patient stated the hcp did a refill and an increase of the medication which did not resolve the issue.The patient then had a x ray done and the connection between catheter and pump was fine.Patient had a dye study done yesterday and they discovered the fluid was not reaching the tip of the catheter.Patient stated the "spasticity was off the charts" but did not have a fever.Patient mentioned the first pump had issues then later clarified the catheter had became detached from the pump due to scar tissue growing around it and pulled the catheter off the pump then lead to withdrawal.Patient stated when the pump was replaced due to normal battery depletion the hcp (healthcare provider) checked the catheter and determined the catheter at that time was good to reuse with the new pump.The patient had a hematoma/bleeding and swelling after the surgery because they didn't cauterize things correctly.Patient was black/blue and had a lot of swelling so they was suspecting the pressure from the swelling could have damaged this catheter.Patient was redirected to their hcp.

Manufacturer Narrative

H3 ¿ analysis of the pump found no anomaly.Analysis of the catheter (model 8780) found ¿catheter body ¿ kink observed¿ and ¿catheter body damage to transition tube¿.Analysis of the connector (model 8785) found no significant anomaly.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.

Manufacturer Narrative

Continuation of d10: product id 8780, serial# (b)(6), product type catheter.Product id 8785 lot# n7 29195, product type catheter.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: 14142983
• MDR Text Key: 290806103
• Report Number: 3004209178-2022-04963
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• 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?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2021
• 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: 57 YR
• Patient Sex: Male