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

Model Number 8637-20

Device Problem Insufficient Information (3190)

Patient Problems Tachycardia (2095); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Irritability (2421); Sleep Dysfunction (2517)

Event Date 10/01/2019

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 consumer regarding a patient receiving baclofen dose and concentration not reported via an implantable pump.On (b)(6) 2020 it was reported that the healthcare provider didn¿t think the pump was working.Per the reporter as of last week the healthcare provider felt the pump should have reached a point where its effectiveness allowed the patient to go off the oral baclofen completely; however, this was not the case.The reporter stated that the healthcare provider feels there might be something she can¿t see which was why they need to go in to do surgery.The patient has "storming events," his heart rate goes up to 190 and it takes forever to calm him down.Valium doesn't even help the patient sometimes and nobody can say why this is happening.The patient ended up in the hospital 2.5 weeks ago, on the (b)(6), they had to give him "proposal" to try and calm him.He had been up for 36 hours straight.Per the reporter everyone thought it was baclofen withdrawal.The patient had a uti (urinary tract infection) but that was resolved and had another storming event on monday night, and it took from 8pm to after 2am to calm the patient down.This was getting more and more frequent and the patient had one where he didn't sleep for the entire night and then ended up sleeping for 3 days where they couldn't wake him.Before the patient was admitted to the hospital the patient had an increase of oral baclofen by 30%.He went from getting 30 mg 3 times per day to 90 mg to 120 mg.They went up on his pump as well.The reporter stated that the pump was set to die in (b)(6) and there are no records or notes on where the catheter was actually placed so they have nothing to go off of.The reporter had not received a call back from the healthcare provider.No further complications were reported regarding the event.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10199380
• MDR Text Key: 196564754
• Report Number: 3004209178-2020-11106
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2020
• Date Device Manufactured: 12/26/2013
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 13 YR