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

Model Number 8637-20

Device Problems Break (1069); Insufficient Flow or Under Infusion (2182); Material Integrity Problem (2978)

Patient Problems Cramp(s) (2193); Therapeutic Response, Decreased (2271); No Code Available (3191)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), product type: catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a company representative (rep) regarding a patient receiving an unknown intrathecal medication via an implanted pump for intractable spasticity.The patient felt like their leg cramps up about once a month.It was noted the healthcare provider (hcp) had checked the pump logs each time during the refills and had not found an issue with the pump.The rep had also read the pump logs and there were no anomalies.At this point, the healthcare provider (hcp) was not going to replace the pump if there was no issue with it.The rep would follow-up with the hcp.The event date was 2017 (about 5 months ago).No further complications were reported/anticipated or expected.Additional information was received from a healthcare provider (hcp) via the manufacturing representative (rep) on (b)(6) 2018.It was reported device had been delivering compounded baclofen, with an unknown dose and concentration.The rep had been told by the hcp that the pump had been working well for the first year to 14 months after implant.Since then, the patient had been experiencing "episodic incidences" where the patient would present with withdrawal symptoms.The hcp would supplement with oral baclofen and the patient would return to normal, before it would start over again.The rep planned to follow-up with the hcp.The pump logs showed no problems and the hcp said the catheter had "aspirated fine" when they accessed the catheter access port (cap).It was reviewed there was the option to check the pump reservoir for accuracy and the option of doing a dye study.It was reviewed the hcp could consider non-system causes.It was indicated the symptoms had begun over the past 4-5 months.Additional information was received from a health care provider (hcp) via a device manufacturer representative on (b)(6) 2018.It was reported that the doctor performed a catheter revision and a pump replacement on (b)(6) 2018.A small piece of the catheter was sheared near the pump connector.That section of the catheter was replaced.The new catheter aspirated freely.There were no known environmental, external or patient factors which may have led or contributed to the issue.It was unknown if the issue was resolved.No further complications were reported.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.The returned pump was interrogated and as per the logs the following medications were being administered as of (b)(6) 2018: baclofen with concentration 1 ,500.0 mcg/ml at dose rate of 511.4 mcg/day, and morphine with concentration 1,500.0 mcg/ml at a dose rate of 511.4 mcg/day.If information is provided in the future, a supplemental report will be issued.

Event Description

The pump and catheter were returned to the manufacturer for analysis.

Manufacturer Narrative

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.

Manufacturer Narrative

Evaluation of implantable pump (b)(4) revealed underinfusion in the lab with an undetermined root cause.Evaluation of implantable catheter (b)(4) revealed damage to the transition tubing.The catheter was found to be patent, and passed pressure leak testing in the lab.(b)(4).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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7722959
• MDR Text Key: 115127173
• Report Number: 3004209178-2018-16714
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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
• Patient Age: 40 YR