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

Model Number 8637-40

Device Problems Kinked (1339); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)

Patient Problems Muscular Rigidity (1968); Therapeutic Effects, Unexpected (2099)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer's representative (rep) regarding a patient receiving 2,000 mcg/ml unknown baclofen at an unknown daily dose via an implantable infusion pump for intractable spasticity and post spinal cord injury.It was reported that they got back a lot more than expected, the actual reservoir volume was 35 ml and the expected reservoir volume was unknown.This was the first refill after the pump was replaced back in (b)(6) 2017.When the pump and catheter were replaced, they were able to aspirate from the catheter access port (cap) successfully.Ever since then, the patient was titrated up and the dose had reached 1,500 mcg/day which was a lot more than the patient ever had been on so they knew there was something wrong.The rep did not believe the pump logs had been checked yet.The patient had increased spasticity in their upper extremity.Ever since the replacement, they were not able to get the dosing correct so it would help the patient.No further complications were expected or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the expected reservoir volume was 3.5 ml.As an action/intervention the patient had a rotor study on (b)(4) 2018 showing the pump to be functioning normally.The hcp could not aspirate drug from the catheter port.The patient was taken to surgery on (b)(4) 2018 for catheter revision.The pump segment of the catheter was found to be kinked by a suture and was replaced.The event was resolved.

Manufacturer Narrative

The relevant components include: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

(b)(4) 2017 crts 3650532 (hcp, rep): information was received from a healthcare professional (hcp) via a manufacturer's representative (rep) regarding a patient receiving 2,000 mcg/ml unknown baclofen at an unknown daily dose via an implantable infusion pump for intractable spasticity and post spinal cord injury.Additional information was received from a healthcare professional (hcp) via a manufacturer's representative (rep).It was reported that they were conducting a catheter dye study and possibly a roller study today.The hcp felt there was no reason why the patient should have an issue receiving the dose from the roller study programming.The patient had been on po baclofen the whole time.They were anticipating a catheter revision and would send the affected catheter back to the manufacturer for analysis.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer (con).It was reported that the catheter was changed because the patient was not getting medicine due to having a catheter kink.At one time the patient had her pump dose over a thousand (thought mcgs) and she still was not getting anything.There was a volume discrepancy and they took out exactly what was put in.The kink was right near the pump.Therapy was not working and the patient had to take 120 mg of oral baclofen.

• 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: 7163833
• MDR Text Key: 96628824
• Report Number: 3004209178-2018-00204
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2018
• Date Device Manufactured: 08/04/2017
• 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: 50 YR
• Patient Weight: 54