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

Model Number 8637-20

Device Problems Obstruction of Flow (2423); Device Ingredient or Reagent Problem (2910); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Itching Sensation (1943); Muscular Rigidity (1968); Pain (1994); Therapeutic Effects, Unexpected (2099); Thrombosis (2100); Twitching (2172); Dysphasia (2195); Distress (2329); Discomfort (2330); Complaint, Ill-Defined (2331); Irritability (2421); Sleep Dysfunction (2517); Constipation (3274)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was initially received from the consumer on 2019-aug-30 regarding a patient receiving baclofen at an unknown concentration and dose via an implantable infusion pump.The indication for use was intractable spasticity.It was reported that the patient was having sleep disturbances since the catheter was revised and was very irritable.It was noted that the pump medication was increased yesterday and that the healthcare provider (hcp) reduced the amount of oral medication from 60mg to 30mg.The caller stated that the patient had a hard time breathing and have saliva everywhere.The caller inquired about the cause of the symptoms and how to correct the issue.On 2019-sep-03 a healthcare provider reported that the pain was likely post-operative.It was reported that the issue was resolved by managing the pain.On 2019-oct-07 a consumer (patient¿s mother) further reported that since the catheter revision performed on (b)(6) 2019 the patient experienced new symptoms.They were questioning if there was a way to test if the patient was getting too much drug or had allergies.The patient was having more spasticity and was tight since the revision.The patient was described as itchy, 'profanity', and twitchy.The patient was noted as being short fused and their personality was different.The reporter was wondering if the patient was allergic to drug.The patient was in a lot of distress at night since the catheter revision.The patient had not been speaking since (b)(6) 2019 after the catheter revision and the catheter was placed higher up by the shoulder blades.After the revision the patient was on hydrocodone as well as oral baclofen and the patient couldn¿t not handle those and it their bowels were impacted, like their colon ¿has gone to sleep¿.The were wondering if drug was impacting their bowels.After revision pump the pump was running at a higher flow rate but patient was having more spasticity.It was noted that a neurosurgeon referred the patient back to their primary physician for testing.Approximately 2.5 to 3 weeks after the catheter revision a healthcare provider was able to back draw spinal fluid and it was tan colored.It was noted that it should instead be clear, and that the catheter could have a kink or clog.The patient had been going to see a physician who gave the patient a bolus of 50cc and took the patient to er at umnc.2.5 hours was indicated, and the physician said the patient was better and turned drug up.However, then the patient later that day was having the same discomfort and stress.The patient had tests in emergency room (er).Days later the patient was in pain.The patient went to an er at methodist hospital and the patient then got second opinion by another physician.Another healthcare provider thought the pump was working ok but did not do dye test but did an x-ray.Right now, a physician was eliminating variables in case something else was going on.It was noted that the patient wanted out of her wheel chair and that was different since revision also.The patient did not want the drug turned up.The reporter was questioning if the bowels were blocked and if that could be causing pain which would override the pump.The patient was told by a neurosurgeon to meet with the primary care physician to see if there was something else going on and was meeting with the managing physician on (b)(6) 2019.The pump was currently administering gablofen of an unknown concentration at an unknown dose rate.Additional information was later received from a consumer on 2019-oct-10.It was noted that oral baclofen "distressed" the patient¿s swallowing and stated that the intrathecal baclofen works much better.Since the new catheter had been placed on (b)(6) 2019, the patient was still in "a lot of discomfort" and had "a lot of constipation".They were worried about if the "baclofen" or "gablofen"was the problem and that it could be other issues, but they are not sure.They contacted the manufacturer of the gablofen, and caller stated the manufacturer didn't think the patient would have a "hypersensitivity" to the gablofen.The patient had their pump turned up higher than it ever has been now, and the patient was still so spastic.The patient used to have the flow rate of ¿115¿ and now the flow rate was at "like 240" and the patient still had spasticity.Because of all of this, the patient was given an mri (magnetic resonance imaging) and they thought the patient should have been awake for it but stated that it would be difficult for patient to be awake for an mri due to not being able to lay perfectly still.The patient was described as being a quad and she was trapped in her body.The reporter was considering if a dye study to check the pump/catheter should be performed and if the patient should have the pump removed and stop the treatment.The patient had an appointment with their hcp today.It was noted that the situation was being addressed via a healthcare provider.No further complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider indicated that there was no correlation to the patient's reported symptoms and the device or therapy.It was reported that an x-ray was performed and the results were entirely normal of the pump and catheter.A magnetic resonance imaging (mri) was performed and no issue was noted.The hcp stated that the patient had no function or effective drug response post revision until after the side port was aspirated.Post aspiration the patient showed good baclofen effect.It was suspected that since the full catheter was not replaced there may had been tissue or a blood clot in the tubing which was cleared.It was reported that during the initial aspiration attempt thicker serous fluid was drawn (2-3 drops) which was cleared with 10-12 cc of freely drawn cerebrospinal fluid (csf).A 2nd side port aspiration was performed a week later and 12 cc of clear csf was drawn.It was noted that the catheter was tested negative for a kink or disconnection.The issue was reported as resolved.No further complications have been reported.

• 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: 9219128
• MDR Text Key: 173385794
• Report Number: 3004209178-2019-19967
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2019
• Date Device Manufactured: 02/19/2015
• 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: 45 YR