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

Model Number 8637-20

Device Problems Filling Problem (1233); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330); Sedation (2368); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving morphine 10 mg/ml; 1.522 to 1.223 mg/day and bupivacaine 3 mg/ml;0.4565 to 0.367 mg/day via an implantable pump.Indication for use was spinal pain.The date of the event was unknown.It was reported a pump volume discrepancy occurred at the refill on (b)(6) 2018.The actual residual volume (arv) 6.1 ml was greater than expected residual volume (erv) 2.4 ml.This was the first time refilling the pump since the patient returned from (b)(6).The patient had a physician in (b)(6) that managed the pump for six months and a physician in oh managed the pump the other six months.The last pump refill in (b)(6) was (b)(6) 2017.The dose was adjusted by 20 percent back in (b)(6) 2018 "reducing the med to go longer".In (b)(6) the physician either never aspirated any drug during the refill or a very small amount and the low reservoir alarm was set to 2 mls, but the pump never alarmed.The pump was refilled 3-4 times in (b)(6).The physician did not use betadine to clean the pump area.It took 10 times to try to access the pump.No aseptic technique was utilized, and fluoroscopy was used during the refill.The patient was alert and oriented and the patient¿s girlfriend was in the room with the patient during the refills.The patient was "big bellied/obese in mid-section, but you could see the pump clearly, so fluoroscopy would not be necessary.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).The patient reported he did not witness any removal of old drug during refills.Refill dictation states he did.The cause of the volume discrepancy was unknown.No symptoms were identified as related the volume discrepancy.The patient was sleepier than normal and had other medical issues as well.Since the first refill at the office (since in (b)(6)) the hcp removed all old medication and documented in the chart.The volume discrepancy had been resolved for the last refill.The hcp wont know until the next refill which will be at next provider of care in (b)(6).The patient is not returning to the original doctor in (b)(6).The patient spends summer in ohio and winter in (b)(6).The patient weight was unknown.Per telemetry printout from last fill in (b)(6) (b)(6) 2018 the pump was delivering morphine 1.901 mg/day and bupivacaine 0.5702 mg/day.

Event Description

Additional information was received from a healthcare provider (hcp).On (b)(6) 2018, the patient contacted the hcp requesting a pump i nterrogation.The patient had been in pain since his last fill.The patient wondered if the dosage was lowered as this was not the relief he had before the last fill.The pump was interrogated and there was a marked difference in concentration and daily dose since patient¿s last visit with the hcp in (b)(6) 2017.The current concentration morphine 10 mg/ml; 1.901 mg/day with bupivacaine 3 mg/ml; 0.5702mg/day.(b)(6) 2017 daily dose: morphine 0.6655mg with bupivacaine 0.1996mg).The patient stated that ever since the last fill in florida he had a bad increase in pain and "something just doesn't seem right".The patient was having increase in bilateral hip and low back/sacral pain.The patient had hip injections in the past.The patient has an appointment 6-15 with the hcp and can be evaluated at that time.Per clinic notes the patient followed up with the hcp on (b)(6) 2018, for low back and left hip pain; quality of pain ache, spasms, stab.The patient was on xarelto, has clot in right calf(b)(6) 2018, while in florida.The patient was at the hcp¿s with his wife and just came back from florida and wants to reestablish care.The patient planned to stay in ohio for 6 months and in florida for the other 6 months.The intrathecal notes from the clinic in florida were reviewed and the intrathecal rate was triple over the past few months.The patient did not feel that the pump was working.Every time the rate increased the pain was worse and themuscle spasms were worse.The patient was asked about the increased intrathecal morphine.The patient was keeping the same oral dose of oxycodone.The patient's wife believed the pateint was more sedated than before.The patient did not really care about the intrathecal morphine as he was not getting any relief.The patient wanted to continue with the oral oxycodone and believed the baclofen was very helpful to spasms.However, the patient requested another muscle relaxant as his main concern was the severe muscle spasms in his back.When the patient was switched from neurontin to lyrica he started to notice skin rash in both legs and swelling.The patient attributed this to the lyrica.The hcp advised the patient that the lyrica would be stopped and the patient would restart back on neurontin as he was tolerating neurontin very well.Of note the patient had a history of deep vein thrombosis (dvt) right leg in march and was currently on xeralto.Lately the left hip was hurting him more.The patient felt that something was popping with activities.The patient requested another xray to make sure everything looks okay.The patient experienced painful range of motion in left hip, increased pain on extension and rotation, positive stiffness and mild to moderate tenderness over the lumbar paraspinal muscles left greater than right.Per clinic notes on (b)(6) 2018, , the patient followed up with the physician for refill and low back, left hip and leg pain.The pain was stinging, aching and shooting.The patient was last seen in office on (b)(6) 2018,.The patient was involved in a motor vehicle accident (mva) the previous week.The patient went to the emergency room and had computeri zed tomography (ct) scan and x-rays.The patient had persistent low back pain across both sides with intermittent radiation into both hips/buttocks, left more than right.The patient had pain and muscle spasms in his legs and states this remains his worst problem and felt most of his pain; left more than right.X-rays of pelvis and hips were negative.Positive stiffness and mild/moderate tenderness over the lumbar paraspinal muscles left greater than right painful range of motion to lumbar spine increased pain on extension and rotation.The pump was decreased at the last visit which he states has been helpful.The patient was more alert, functioning and less depressed.The patient was using oxycodone 15mg, 4 per day; neurontin 4800 mg/day; baclofen 60 mg/day; zanaflex 8mg/day, he reports benefit for function without adverse effects.Positive stiffness and mild/mod tenderness over the.Lumbar paraspinal muscles, l> r; painful rom to lumbar spine; increased pain on extension and rotation.Per clinic notes the patient had an office visit on (b)(6) 2018, for a pump refill.The patient experienced pain in the low back and left hip described as stinging, aching, shooting.The patient had positive stiffness and mild/moderate tenderness over the lumbar paraspinal muscles.Left greater than right.Painful range of motion to lumbar spine increased pain on extension and rotation.The patient uses a cane for ambulation.The patient reported many times that the pump is not helpful and wants to continue oral medications.The pump was refilled with morphine: 10mg/ml; 1.223 mg with bupivacaine 3mg/ml;0.367 mg.Decreasing daily dose 20%-- new daily dose: morphine 1.223mg with bupivacaine: 0.367mg.The patient tolerated the refill well.Pump reservoir volume discrepancy (expected 2.4 ml, removed 6.1ml).Allergies vancomycin: rash, tachycardia adhesive tape: blisters.Hospitalization/major diagnosticprocedure: cellulitis bilateral lower legs (b)(6) 2012.Wound care after i<(>&<)>d symptoms on bilateral heels (b)(6) 2012.Amputation of bone and complete 5th toe on left foot.Er visit (auto accident) (b)(6) 2018.Imaging done date/type in florida, 7/10/18 ct of the neck and head, (b)(6) 2018 x-ray of lumbar.Assessments sacroiliitis, not elsewhere classified.Postlaminectomy syndrome, thoracic region, lumbosacral neuritis, other imervertebral disc degeneration, lumbar region, drug induced constipation, lumbosacral spondylosis without myelopathy.Surgical history: partial resection of spinal tumor, colon resection due to diverticulitis 2006, bladder repair 2006, incision and drainage (i<(>&<)>d) bilateral heel ulcers(b)(6) 2012, ri ght fifth toe foot amputation (b)(6) 2013, amputation of bone under 5th toe on left foot (b)(6) 2014, amputation trans metatarsal right foot on (b)(6) 2016, amputation of bone and complete 5th toe on left foot, left ankle tendon release(b)(6) 2017.Amputation trans metatarsal right foot (b)(6) 2016, post laminectomy syndrome.Past medical history includes depression, copd, degenerative arthritis, bipolar disorder, diabetes average fbs 120¿s, hypercholesterolemia, peripheral neuropathy.Ddd/dd, lumbar tumor 2006 (associated symptoms numbness, tingling, weakness in h/1 leg, b/1 hand, and all fingers).Diverticulitis.B/ l heel ulcers.Wound vac to left foot (to be removed 8-8-14, 2016).Left hip pain- oa.Tobacco abuse.(b)(6) 2017 left foot bone infection with hospitalization, (b)(6) 2018 right calf clot.Sacroilitis, lumbosacral neuritis, other intervertebral disc degeneration lumbar region, drug induced constipation, lumbosacral spondylosis without myelopathy.Current medications on (b)(6) 2018, aspirin 81 mg tablet delayed 1 tablet orally once a day, baclofen 20 mg tablet 1 tablet with food or milk orally every 8 hours, colace 100 mg capsule 1 capsule as needed orally once a day, crestor 20 mg tablet orally once a day, furosemide 40 mg tablet 1 tablet orally once a day klonopin 2 mg tablet 1 tablet at bedtime orally once a day, levothyroxine sodium 25 mcg tablet 1 tablet on an empty stomach in the m orning orally once a day losartan potassium 25 mg tablet 1 tablet orally once a day, miralax packet 1 packet mixed with 8 ounces of fluid orally once a day, neurontin 800 mg capsule 1 capsule orally four times daily, oxycodone hcl 15 mg tablet 1tablet orally every 6 hours, tresiba flextouch 100 unit/ml solution peninjector subcutaneous 46 units qhs xarelto 20 mg tablet 1 tablet with food orally once a day, zanaflex 4 mg tablet 1 tablet as needed orally bid.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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
• MDR Report Key: 7902101
• MDR Text Key: 122523783
• Report Number: 3004209178-2018-21349
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1