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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problems Foreign Body Reaction (1868); Low Blood Pressure/ Hypotension (1914); Muscular Rigidity (1968); Pain (1994); Rash (2033); Therapeutic Response, Decreased (2271); Numbness (2415)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

References the main component of the device system; the other relevant components include: product id: 8782, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter.(b)(4).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 provider (hcp) via a clinical study regarding a patient receiving morphine, bupivacaine, and compounded baclofen at concentrations of 1.0 mg/ml, 30.0 mg/ml, 150.0 mcg/ml and doses of 0.2471 mcg/day, 7.414 mg/day, 37.07 mcg/day via an implantable pump.The indication for use was non-malignant pain.It was reported the patient had persistent neck pain and decreased range of motion on (b)(6) 2017.A catheter dye study was performed on (b)(6) 2017 and the results were normal.Dye was streaming cephalad and caudad but only in the right gutter.It was noted the patient also suffered a spinal anesthetic during the procedure even though 3 ml of csf was aspirated from the catheter before infusing.Three ml were aspirated from the catheter, dye was injected, and then the patient reported feeling funny and her blood pressure dropped to the 60's.Oxygen and zofran were administered.The patient was monitored until their vitals stabilized.The patient also experienced lower extremity numbness following the dye study which subsided without intervention.The pump was decreased following the dye study.The next day the patient reported increased pain following the rate decrease so the pump was increased.It was indicated the event was related to the device or therapy.The device diagnosis was listed as catheter dislodgement and the clinical diagnosis was persistent pain with right lower extremity pain.The catheter was repositioned on (b)(6) 2017 and the catheter was pulled down t8 from t5.The issue was noted as resolved without sequelae on (b)(6) 2017.

Event Description

Additional information received from a healthcare provider via a clinical study reported the clinical diagnosis as it medications pooling in the right gutter.A catheter access port (cap) contrast study was performed on (b)(6) 2017 with the results showing medications pooling in the intrathecal space right gutter.It was indicated the event was related to the device or therapy and related to the drugs morphine, bupivacaine, and compounded baclofen.The device diagnosis was updated to catheter dislodgement and the clinical diagnosis was updated to new persistent neck pain.Surgical observation was performed on (b)(6) 2017 and it was noted the catheter had migrated from t6 to t8.The patient's typical pain including lower extremity pain also continued at onset of the event.It was also mentioned that during a pre-operative visit on (b)(6) 2017 for the catheter revision, the catheter might be replaced with a 8709 catheter, as the patient might have been having a reaction to the silicone.It was indicated the reaction was possibly related to the device or therapy.The catheter was not replaced and the existing catheter was repositioned.The specific symptoms of the suspected reaction was not noted.No further intervention.No actions were taken and the reaction was unresolved with no further actions planned.

Manufacturer Narrative

(b)(4).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 received from a healthcare provider (hcp) reported the patient past medications included botox, cefadroxil, diclofenac sodium started on (b)(6) 2015.The patient received a flector transdermal patch and folic acid started on (b)(6) 2017.The same day the patient was prescribed imitrex, meloxicam, orencia, orencia clickject, prednisone, probiotic colon support capsule, and zofran.On (b)(6) 2017, the patient was prescribed topicaine, topical gel, vagifem, and a vaginal tab.It was later specified the patient had botox injections on (b)(6) 2016 at the migraine sites.The patient also had a cervical medial branch block at the right initial c3, c4, c5, c6 and a cervical medical branch block on the left c3,c4,c5,c6 on (b)(6) 2017.On (b)(6) 2017, the patient was prescribed keflex, meloxicam, orencia, orencia clickject, prednisone, and probiotic colon support capsule.The patient's allergies included levofloxacin, ketorolac, tromethamine, non-steroidal anti-inflammatory drug, nitrofurantoin, ciprofloxacin, hcl, cephalexin, and monohydrate.The patient's medical history included a history of kidney stones with removal x3, history of ovarian carcinosarcoma, gastroesophageal reflux disease, hypothyroid, insomnia, interstitial cystitis, rheumatoid arthritis, irritable bowel syndrome, lupus, headache, and migraines.It was reported the patient had an appointment on (b)(6) 2017 and their general pain was at a level of 4/10 and their back and/or leg pain was noted to be 6/10.The patient had their systems reviewed and were positive for numbness in extremities and positive for back pain, joint pain, neck pain.A physical exam was performed with all results coming back normal.The patient had a medial branch nerve block on right c3-c6 on (b)(6) 2017.The patient noted 90-95% relief and continued having decrease in pain.The patient had increased range of motion, can turn head, and had lateral flexion when they were unable to do so before.It was noted the patient's spasms in their right leg would cause the patient's neck to tense up and cause pain.A second medial branch nerve block was to be scheduled soon.The patient plan included a dye study that was ordered and submitted on (b)(6) 2017.The patient was ordered to continue flector patches and use of the personal therapy manager, ptm, as needed for breakthrough pain.The pump was interrogated on this date but no changes were made.The patient was encouraged to learn relaxation methods like deep breathing, stretching, and meditation to help with muscle relaxation.The patient was also encouraged to keep hydrated by drinking 3 liters or more of water daily.The patient was informed spasms and nerve pain respond well to moist heat as it help to vasodilate vessels and increase oxygen to these areas.The assessment of the patient's headaches concluded that patient was stable with their headaches and were instructed to continue topamax and imitrex as well as start using lidocaine 5 % gel to affected area.The patient's nausea and vomiting was assessed and it was noted the patient was managing their nausea on their current regiment with no reported side effects.The patient was instructed to continue zofran as needed.The patient's insomnia was assessed and it was noted the patient had been able to sleep all night since the procedure on (b)(6) 2017.The patient was advised to try relaxation or mediation before going to bed and refrain from napping as it would disrupt sleep cycle.The patient also may try melatonin 10 mg a night in order to correct sleep cycle if needed.It was noted the patient was experiencing a permanent state of charley horse with massive spasms on their right calf, hamstring, and neck.The patient had a second appointment on (b)(6) 2017 to perform a catheter dye study.The catheter dye study was normal with the pump system intact and functional.The catheter tip was noted to be between the t7 and t8 when it was originally placed at t6.Dye was seen streaming cephalad and caudad but only in the right gutter.The patient's catheter was able to be aspirated 3 ml.After the dye was injected the patient reported feeling funny.The patient's blood pressure dropped to the 60's and oxygen was administered with the patient being placed in reverse trendelenberg.It was noted the catheter system required surgical catheter revision.The patient suffered a spinal anesthetic even though 3 ml of cerebrospinal fluid was aspirated from the catheter before infusing.The patient was monitored and placed on oxygen until vital signs stabilized and sensation returned to normal.The patient was given an im injection of zofran 8 mg in the right glute and promethazine 2 mcg administered in the right buttocks at 05:57 pm.The patient had an appointment the next day on (b)(6) 2017 and the patient reported their pain as a 4/10 and their back and/or leg pain at 7/10.Th e patient's systems were reviewed and the patient was positive for fatigue, constipation, nausea, urinary incontinence, urinary retention, extremity weakness, headache, memory impairment, numbness in extremity, anxiety, rash, back pain, joint pain, muscle weakness, and neck pain.The patient had a neurological exam and everything was normal.The patient's pump was analyzed and reprogrammed with the drug morphine was increased from 0.1798 mg/day to 0.1997 mg/day, bupivacaine increased from 5.394 mg/day to 5.991 mg/day, and baclofen increased from 1.798 mcg/day to 1.997 mcg/day.The patient was discharged in a stable condition.The patient's radiculopathy was assessed on (b)(6) 2017 and the patient reported their cervical spine was stable at the time.After the dye study the patient had increased numbness in the legs but has subsided.The pump was interrogated and the daily rate was increased to help with the increased pain.The patient was instructed to continue ptm use as needed for breakthrough pain.It was noted a catheter replacement was planned to replace the current catheter with an old catheter as the patient may have been having a reaction to the silicone.It was reported the patient's headaches continue to be present but managed with botox and medications.The patient was instructed to continue topamax, imitrex, and lidocaine 5% gel as needed.The patient continues to deal with nausea and continues to take zofran as needed.The patient's radiculopathy was assessed the patient reported increased pain in their tailbone.The pump was interrogated and the daily rate was increased today to help with the increased pain.The patient had an office visit on (b)(6) 2017 and the patient reported their pain level was a 7/10 and their back and/or leg pain at a level as of 7/10.The patient's systems were review and the patient was fatigued, headache, numbness in extremity, rash, back pain, joint pain, muscle weakness, and neck pain.The patient had a physical exam with all results normal.The patient's radiculopathy was assessed and it was noted the a patient's pain in their cervical spine is stable at this time.The pump was interrogated and no changes were made.The patient was instructed to continue ptm use for breakthrough pain as needed.Continue medial branch nerve block on right c3-c6 in order to get the rfa.The patient was scheduled for catheter replacement.The patient continued to experience lower back pain and acute spasm episodes throughout the day in their right leg and attributes this to the pump.The patient's nausea and vomiting were assessed and the patient continues to deal with nausea.The patient was instructed to continue zofran as needed.The patient continued to have headaches but managed with botox and medications.The patient was instructed to continue topamax, imitrex, and lidocaine 5% gel.The patient had an office visit for the intrathecal catheter dye study and revision on (b)(6) 2017.The preoperative diagnosis was loss of pain relief, right lower extremity pain secondary to medications pooling in the intrathecal space right gutter, and history lumbosacral radiculopathy.The catheter dye study and revision were performed on (b)(6) 2017.The patent returned to the recovery room without incident.

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.

Event Description

Additional information received from a healthcare provider (hcp) via a clinical study indicated the etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The device involved was the intrathecal/spinal portion of the catheter.No further complications were reported/anticipated.

• 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: 6460790
• MDR Text Key: 71742726
• Report Number: 3004209178-2017-07072
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• Date Device Manufactured: 06/12/2013
• 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): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 48