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

Model Number 8637-40

Device Problems Device Or Device Fragments Location Unknown (2590); Aspiration Issue (2883); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

Patient Problems Muscle Weakness (1967); Overdose (1988); Pain (1994); Respiratory Distress (2045); Anxiety (2328); Distress (2329); Depression (2361); Sedation (2368); Numbness (2415); Confusion/ Disorientation (2553)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2013, product type: catheter.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) and a manufacturer's representative (rep) regarding a patient receiving 212 mcg/ml fentanyl at a dose of 5.13 mcg/day and 4.2 mg/ml bupivacaine at a dose of 0.1017 mg/day via an implantable infusion pump for spinal pain.It was reported by the rep that a rotor/dye procedure was planned but the hcp was unable to aspirate the catheter so they did an mri.A revision was set up for a couple of weeks from now.The pump was set to minimum rate.Additional information was received from a healthcare professional (hcp).It was reported that the patient's chief complaint was low back pain.The patient had weakness and numbness in her back.The pain would make the patient feel frustrated, angry, and depressed as it would interfere with her work, daily activities, and sleep.On (b)(6) 2016 the patient presented to the hcp's office for follow-up.In (b)(6) 2016 she had a pumpogram that showed the catheter may have a possible kink and the hcp was unable to aspirate cerebrospinal fluid (csf).At that time her pump medication was diluted and she was given a prescription for percocet.The patient was transported to the emergency room last week with respiratory depression as she had an unintentional overdose and had used 90 percocet in less than 10 days.She was seen for confusion and excessive sedation and was inpatient for 3 days starting on (b)(6) 2016.This visit was unrelated to her pain problem.While in the hospital she was given two doses of narcan and recovered.The patient was also taking clonazepam for her anxiety at the time.Patient was currently taking baclofen, ibuprofen, and gabapentin for pain and denied any adverse effects.Patient was scheduled for a pump replacement and catheter revision at the end of (b)(6) 2017.A lumbar and thoracic spine mri was ordered withand without contrast to rule out granuloma at the site of the catheter tip at t11.The results of the mri showed no evidence of significant central canal or neuroforaminal compromise.The pump was decreased to minimum settings.Patient had a medical history of l4-s1 fusion in 2006, chronic back and leg pain, emg showing left l5 radiculopathy, gallbladder removed (b)(6) 2016, sinus endoscopy,bilateral carpal tunnel, right knee arthroscopy, hypercholesterolemia, heart disease, labia cyst, eh lers-danlos syndrome, kidney stones, peripheral neuropathy, hypertension, diabetes, depression, asthma, and arthritis.Patient was currently taking the following medications: citalopram (40mg), toprol (100mg), paroxetine (40mg), clonazepam (2mg), miralax (17g), and gapatentin (600mg), baclofen (10mg), clonidine hcl (0.1mg), ibuprofen (800mg).Patient was allergic to sulfamethoxazole, trimethoprim, red dye, penicillins, and strawberry.

Event Description

Additional information received from the representative reported the magnetic resonance imaging (mri) procedure was done that day ((b)(6) 2017) at 14:07.The stall via the event logs with the 8840 time was incorrect, so the representative believed it was more like 14:24-14:30.The representative began interrogating the pump to confirm the stall recovery approximately 45 minutes before the call and had continued to re-interrogate the pump, but there had been no motor stall recovery logged yet.The representative would continue to re-interrogate the pump after 20 minutes to confirm the stall recovery.Additional information received from the representative on 2017-jan-17 reported the patient had left before they could confirm stall recovery.

Manufacturer Narrative

The other relevant components include: product id: 8780, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2017, product type: catheter.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).

Event Description

Additional information was received from a hcp via a rep on 2017-feb-28.It was reported that the pump and the catheter not working, so everything was replaced.They were explanted and replaced with a device of the same manufacturer.The issue was resolved at the time of the report, with the patient alive and without injury.The drug being delivered was 100 mcg/ml fentanyl with a dosage of 40 mcg/day.The device would be returned to the manufacturer, as it was in possession of the rep.The hcp would have no further information on this event.The patient weight was asked and unknown, and would not be made available (legal/confidential reason).Information received from the rep on 2017-mar-07 indicated that the device was returned to the manufacturer for analysis.

Manufacturer Narrative

Updated from regulatory report #3004209178-2017-00426.Follow up 003 to reflect the current information.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a hcp via a rep on 2017-feb-28.The report indicated destructive analysis.It was reported that the pump and the catheter not working, so everything was replaced.They were explanted and replaced with a device of the same manufacturer.A portion of the catheter remains in the patient, and out of service.The issue was resolved at the time of the report, with the patient alive and without injury.The drug being delivered was 100 mcg/ml fentanyl with a dosage of 40 mcg/day.The device would be returned to the manufacturer, as it was in possession of the rep.The hcp would have no further information on this event.The patient weight was asked and unknown, and would not be made available (legal/confidential reason).Information received from the rep on 2017-mar-07 indicated that the device was returned to the manufacturer for analysis.

Manufacturer Narrative

Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2013, product type: catheter.Analysis of the pump identified no anomalies.Analysis of the catheter found that there was a tear in the seal near the guide ring of the sc connector.(b)(4).

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.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6232529
• MDR Text Key: 64166865
• Report Number: 3004209178-2017-00426
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0592-2009, Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR