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

Model Number 8637-40

Device Problems Pumping Stopped (1503); Material Integrity Problem (2978)

Patient Problems Memory Loss/Impairment (1958); Muscular Rigidity (1968); Irritability (2421); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  Injury  

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) regarding a patient who was receiving baclofen, unknown (4000mcg/ml at 1482.7 mcg/day) via an implantable pump for intractable spasticity and spinal cord injury/spinal cord disease.It was reported that there was a motor stall on (b)(6) 2021 at 5:17pm.There was no recovery.The patient experienced rebound spasticity, agitation, and forgetfulness.Patient presented to the clinic on (b)(6) 2021 with the pump motor stall.Physician prepared to replace pump same day.However, patient was diagnosed with uti with e.Coli.Sent to hospital for treatment of uti and oral baclofen.Will replace pump when infection is cleared.There were no reported environmental/external/patient factors that may have led or contributed to the issue.There was no troubleshooting performed.The issue was not resolved at the time of the report.Logs were provided and also show a motor stall on (b)(6) 2020 at 10:43am with a recovery on the same day at 11:16am.In the logs, there was also a low reservoir alarm on (b)(6) 2020 followed by an empty reservoir alarm on (b)(6) 2021.There was also a low reservoir alarm on (b)(6) 2021.

Event Description

On 2021-may-24, themanufacturer representative (rep) reported a pump replacement was performed.The catheter was revised because a tear was noted in the catheter.The patient was started on 250 mcg/day of baclofen.Baclofen was 500 mcg/ml in the pump.The physician discarded the removed catheter piece and the pump.

Manufacturer Narrative

Continuation of d10: product id: 8780; lot#serial#: (b)(6); implanted: on (b)(6) 2015; 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.

• 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
• MDR Report Key: 11590218
• MDR Text Key: 242972818
• Report Number: 3004209178-2021-05172
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10."
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 125