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

Model Number 8637-40

Device Problems Filling Problem (1233); Difficult to Interrogate (1331); Unstable (1667); Material Integrity Problem (2978)

Patient Problems Seroma (2069); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8835, serial# (b)(4), product type: programmer, patient.Product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.(b)(4).

Event Description

Information was received from a healthcare provider (hcp) via a company representative in regard to a patient receiving morphine 10 mg/ml at 3 mg/day, and clonidine 200 mcg/ml at 60 mcg/day via an implantable infusion pump.The indication for use (ifu) was listed as chronic intractable pain and non-malignant pain.Office visit notes from (b)(6) 2015 were provided.The patient's chief complaint included multiple pain issues.The patient's pain scale was 6-7 out of 10, blood pressure sitting was 157/111 mg hg, and brachial pulse was 98 bpm.The patient's current problems included cervical disc syndrome w/o myelopathy, uns reflex sympathetic dystrophy, reflex symp dystrophy left upper extremity, episodic mood disorders: endogenous depression single episode or unspecified, gastroparesis, and symptoms involving digestive system: nausea and vomiting.The patient's history included a motor vehicle accident about 16 years prior, a fractured spine, and multiple surgical procedures done since then.They may have been an injury to the vagal nerve.The patient reports that since then she has developed gastroparesis.It was noted that this may have been during pregnancy.Since then she's had a gastric pacemaker placed.The gastric pacemaker helped with the gastroparesis, but the surgery caused her symptoms of complex regional pain syndrome to be exacerbated.The patient was diagnosed with complex regional pain syndrome of the abdomen.The patient's abdomen was listed as hypersensitivity noted possible related to complex regional pain syndrome.The patient had hypersensitivity of the right upper extremity.The patient also history of having had multiple stellate gangrene blocks.This was related to the symptoms of complex regional pain syndrome of the right upper extremity.These procedures helpful initially, but they have not been helpful at present.The patient was under the care of a pain management physician.During the course of treatment, the patient has tried multiple medications and interventional procedures.They have not been very beneficial.At present the patient reports that she also been taking a lot of pain medications, which appear some help.The amount of medication the patient has been taking have been quite extensive and they do cause the patient have nausea.The patient does report that she has undergone ketamine infusion.It appears not to have been very beneficial.The patient has been admitted to the hospital on 2 occasions because of increased abdominal pain.The patient has been given a lot of medications.This was not very beneficial.The patient continues to take a large dose of oral medication.It was discussed the need for her to stop or wean medications during ketamine infusion.The patient has not been able to do so successfully but has reduced the same.The use of ketamine infusion has helped with her upper extremity pain.The patient apparently has complex regional pain syndrome of the upper extremity on the right side.The patient came to the hcp office on (b)(6) 2015 and reports that she continues to have significant abdominal pain.The patient apparently has been receiving fentora tablets 400 mg.The given prescription is for 4 per day, the patient apparently has been using 6 per day.This has resulted in her having to be over using medications.The patient is recently undergone radiofrequency ablation off and therefore nerve neuroma on the abdomen.The patient had relief of pain for about one and a half days.The patient has not returned and it has become more intense and the pain appears to be much more generalized, with more pain on the right side than on the left side.The patient also reports that she has been using excessive amounts of fentora.Her primary pain management physician appears to be reluctant to write these medications.Patient came to the office for regular refill on her intrathecal pump.The patient reported that she was having a lot of nausea.The patient apparently developed tardive dyskinesia due to a problem with haloperidol.On (b)(6) 2015, the patient came into the office and reported not doing well.The patient had surgery on her back for removal of stage ii of 3 melanoma.Since then, the patient has been having significant exacerbation of pain related to complex regional pain syndrome.The patient has been extremely nauseous and there has been significant gastroparesis.As a result the patient has been on a liquid diet.The patient reports that she has been receiving medications intravenously to try and reduce the amount of nausea.On (b)(6) 2015, the patient came to the healthcare provider's office urgently.The patient telemetry for the intrathecal pump did not appear to be working.The patient was unable to give herself a bolus.The patient pain intensity had increased significantly.The pump appeared not to be working very well.Telemetry was performed and the healthcare provider was unable to communicate with the pump.The hcp was able to manipulate the pump.It was noted that it was clear that the pump was flipping with the cavity without any problems.It was noted that this indicated that the pump was completely untethered.This was more than likely because of the fact that the patient was being bent over.After the hcp was able to flex the pump telemetry was performed and the patient was able to get a bolus.It was noted that it appeared that the pump was working.The hcp explained to the patient it was necessary to review position (more laterally was considered) and securing the pump again.It was noted that the hcp had been experiencing difficulty accessing the pump.A revision of the pump was performed on (b)(6) 2015.The patient's pre-op diagnosis included abdominal pain with malfunctioning pump.The post-op diagnosis included abdominal pain with malpositioning of the pump and twisting of the catheter.During the procedure the findings included significant twisting of the catheter was noted.The catheter was not detached or leaking or cut.Everything was intact.The pump was completely mobile.The patient's estimated blood loss during the procedure was 10 ml.The patient was given 600 mg of clindamycin to cover for the procedure.Upon opening the pump pocket, there was a collection of fluid coming out of the cavity.A culture and sensitivity was sent including about 5 cc collected fluid was sent off for analysis.The pump was completely mobile and there were no tethering sutures noted at all.There was a significant amount of twisting of the catheter and this was a problem as it appeared that there may have been a problem with flow of the medication through the catheter.The catheter was disconnected from the pump and the hcp were able to undue the catheter and make it all straight.There was free flow of cerebrospinal fluid (csf) noted through the catheter.The pump was repositioned, the catheter was secured, the pump was emptied and refilled with a combination of morphine 10 mg, and clonidine 200 mg.Telemetry and reprogramming were then completed.The pump was repositioned in a way that it would be more comfortable for the patient.The top part of the pocket was extended upwards towards the chest.Hemostasis was obtained.Antibiotic irrigation was done with bacitracin.Sutures were used to tether the pump and the hcp was able to tether the pump at a much higher position.A stay suture was used to prevent the catheter from being too mobile.There was a large cavity in the lower half of the incision so the cavity was closed using sutures.There was satisfactory closing of the cavity.The patient tolerated the procedure fairly well.The patient was brought to the recovery room in a satisfactory condition.The cause of the flipped pump was unknown.The issue was reported to be resolved.The patient's status at the time of report was alive no injury.The event date was later reported as approximately (b)(6) 2015.The patient had a follow-up meeting scheduled for (b)(6) 2015 for a pump refill ketamine infusion.Current medications provided include: in pump use-low dose naltrexone 3 mg 0.0333 for 30 days, prochlorperazine 10 mg 1 tab every 6 hours, advair diskus 250-50 mcg/dose, using inhaler 1 puff twice per day, ativan 1 mg tablet by mouth for 3 days, ativan 0.5 mg by mouth 2 tabs per day, colace 100 mg by mouth 2 caps per day, lemon ketamine teroche 10 mg 5 for 30 days, cymbalta 60 mg by mouth 1 tab per day, epipen taken as needed, erythromycin base 250 mg by mouth i tab twice per day, fentanyl 75 mcg/hr to affected area 1 every 72 hours, fentora 200 mcg in mouth taken as needed, lmitrex 6 mg/0.5ml subcutaneously injectable as needed, lactulose 10 gm/ml 2 tabs 2-3 times per day, librax 2.5-5 mg by mouth 1 cap 3 times per day, morphine 15 mg tablet 2 tablet by mouth every four hours as needed for pain for 15 days, morphine sulfate uncertain of dosage solution taken as needed, neurontin 800 mg by mouth 3 caps 3 times per day, nexlum 40 mg by mouth 1 cap per day, nortriptyline hci 50 mg by mouth 1 cap per day, promethazone hci 25 mg syrup every 6 hours, pump syringe morphine 10 mg/ml clonidine 200 mcg/ml intrathecal, sancuso 3.1 mg per day to affected area 1 every 7 days, seasonique 0.15-0.03 <(>&<)> 0.01 mg by mouth 1 tab per day, tramadol hci er 200 mg by mouth 1 tab per day, xopenex 1.25mg/3 ml using inhaler as needed, zoloft 100 mg by mouth 75 mg 1 tab per day.Allergies: dilaudid, macrobid, penicillin, reglan - twitching, strawberry swelling.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5038771
• MDR Text Key: 24413195
• Report Number: 3004209178-2015-16910
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• 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: 08/03/2015
• Date Device Manufactured: 03/13/2014
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 00042 YR