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

Model Number 8637-40

Device Problems Filling Problem (1233); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Encephalopathy (1833); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Muscular Rigidity (1968); Nausea (1970); Vomiting (2144); Weakness (2145); Malaise (2359); Loss of consciousness (2418); Ambulation Difficulties (2544); Cognitive Changes (2551); Confusion/ Disorientation (2553); Lethargy (2560)

Event Date 10/30/2018

Event Type  Injury  

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 baclofen of unknown concentration at an unknown dose rate via an implantable pump for intractable spasticity.It was reported that the patient had a dose increase on (b)(6) 2018 and early morning yesterday ((b)(6) 2018) the patient came into the emergency room.The patient was now in the intensive care unit (icu) with altered mental status.A company representative was requested to come to the facility to assist with programming the pump.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received via a healthcare provider (hcp).The patient had a past medical history of multiple sclerosis, meningioma, s/p vp shunt, s/p urostomy/colostomy, hypothyroidism, prior deep vein thrombosis (dvt) / pulmonary hypertension and was admitted to a hospital (b)(6) 2018 due to pneumonia (suspected aspiration).The status of the patient was listed as ¿disabled¿.It was further reported that the patient was in-patient with altered mental status.The date of admission was (b)(6) 2018 and the date of discharge was (b)(6) 2018.It was also noted that the patent presented to the hospital on (b)(6) 2018 (this date is conflicting with the report of date of admission having been (b)(6) 2018) for evaluation of weakness, confusion, nausea with vomiting, and decreased responsiveness.Workup in the emergency department (ed) was fairly unremarkable; however, urinary analysis was consistent with a uti.Urine culture returned positive for klebsiella and enterobacter, both sensitive to rocephin.It was indicated that the patient had noted cloudy/foul smelling urine for three weeks.The patient was started on rocephin intravenously for five days.The patient was to transfer to oral omnicef to complete a total of seven days of therapy.The listed active hospital problems were as follows: nocturnal hypoxia (date noted: (b)(6) 2018), urinary tract infection (date noted: (b)(6) 2018), hypertension (date noted: (b)(6) 2018), history of pulmonary embolus (date noted: (b)(6) 2018), status post (s/p) ventriculoperitoneal (vp) shunt (date noted: (b)(6) 2018), weakness (date noted: (b)(6) 2018), and multiple sclerosis (date noted: (b)(6) 2015).A ct of their head on (b)(6) 2018 was unremarkable; xr series of the vp shunt was normal.Magnetic resonance imaging (mri) of the brain with and without contrast was performed on (b)(6) 2018; a past mri was noted as having been previously performed on (b)(6) 2013.It was further reported that the patient also noted that the rate of her baclofen pump was increased recently and since the change, she had been feeling not quite herself.On the evening of (b)(6) 2018, the patient had vomited, developed hypotension, and worsening mentation.The patient was transferred to the intensive care unit for closer monitoring.Neurology was consulted, and the physician felt the patient¿s confusion was most likely related to her infection or medication effect from baclofen pump increase.It was noted that the pump manufacturer was notified, and her pump was decreased from 575 to 400 mg.It was indicated that the patient would need to follow-up with the neurosurgery team for continued monitoring.It was indicated that the patient was concerned that their pump may have malfunctioned.It was indicated that the patient reported that she had follow-up arranged with her urologist on (b)(6) 2018 and was working to arrange for baclofen pump follow-up.Regarding the day of discharge, the following history of present illness (hpi) was listed as follows: patient was feeling much better, mental status had returned to baseline, no chest painor dyspnea, n/v/d (nausea/vomiting/diarrhea) or constipation was denied, and urostomy was functioning well.It was further indicated that the patient had no fevers, chills, palpitations, cough, or abdominal pain.A review of systems was negative except as mentioned in the hpi.The hospital problems that were resolved as of (b)(6) 2018 were listed as follows: sepsis (¿probably urinary source¿; date noted: (b)(6) 2018), encephalopathy acute (date noted: (b)(6) 2018), and aspiration pneumonia (¿possible¿; date noted: (b)(6) 2018).

Manufacturer Narrative

B1, b2, h1: adverse experience details updated to reflect the information received on 2019-apr-03 b5: updated to reflect the information received on 2019-apr-03 h6: patient codes c3036, c3832, c50412, c50458, c50635, c50659 added, device code updated to c63144 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.- attachment: [medwatch_mw5084927.Pdf].

Event Description

Additional information was received from the consumer via the fda on 2019-apr-03.It was reported that during the pump refill on 2019-oct-29, the healthcare provider (hcp) put the needle into the reservoir to remove the remaining medication, but no medication came out after 2 attempts to aspirate.The patient noted that at the time they were having increased spasticity and requested an increase in their dose.According to the patient, they could immediately see a change after the dosage was increased.However, the patient noted that they began to feel very bad and that their legs were unable to support them as the day progressed on 2019-oct-30.The patient was told to take oral baclofen to help get the baclofen back into their system.The patient then began to have nausea and felt very lethargic and sleepy.The patient's daughter found the patient unresponsive and "laying in [their] own vomit at the top of the stairs in [their] home".An ambulance transported the patient to the hospital where they were unable to lift their lower extremities.The patient was reportedly unresponsive for about 48 hours and their blood pressure dropped very low (80's/40's).After the hospitalization, the patient was admitted to an inpatient rehabilitation hospital where the pump was analyzed.The pump was eventually explanted on (b)(6) 2018.The patient confirmed that a pump malfunction caused life-threatening issues for them.The patient¿s concomitant medications included provigil 200 mg, 1 tab in morning; amantidine 100 mg in morning and 100 mg at noon; marinol 5 mg in evening; coumadin daily dosing regulated by inr levels; 20-40 mg lasix for swelling; 40mg adcirca daily; 10 mg diazepam at bedtime; 4mg tizanidine at bedtime; 20 meq of potassium-daily, 125 mcg synthroid every morning; 10 mg of baclofen as needed; 2 liters of oxygen at bedtime; and miralax.

• 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: 8039577
• MDR Text Key: 126177438
• Report Number: 3004209178-2018-24717
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 01/21/2019; 04/03/2019
• Supplement Dates FDA Received: 01/25/2019; 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 49 YR