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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Infusion or Flow Problem (2964); Insufficient Information (3190)
Patient Problems Calcium Deposits/Calcification (1758); Diarrhea (1811); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Edema (1820); Fatigue (1849); Hair Loss (1877); Head Injury (1879); Headache (1880); Pyrosis/Heartburn (1883); High Blood Pressure/ Hypertension (1908); Impotence (1925); Incontinence (1928); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Visual Impairment (2138); Vomiting (2144); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Hernia (2240); Ulcer (2274); Urinary Frequency (2275); Distress (2329); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Claudication (2550); Weight Changes (2607); No Known Impact Or Consequence To Patient (2692); No Code Available (3191); Constipation (3274)
Event Date 12/09/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the consumer regarding a patient receiving an unknown drug via an implantable infusion pump.It was reported that the pump was replaced on (b)(6) 2019 because it was not working for him.No further complications have been reported as a result of this event.
 
Manufacturer Narrative
Product id 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider reported the catheter wouldn't aspirate when they changed the pump so the system was replaced.The patient's weight was unknown.The current device was working well with no side effects.
 
Manufacturer Narrative
Continuation of d11: product id 8780 lot# serial# (b)(6) implanted: (b)(6) explanted: product type catheter 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.
 
Event Description
Additional information was received from a healthcare professional (hcp).It was reported that the patient was experiencing back pain (middle and lower back), neck pain, and leg pain.The patient back pain was described as burning, pressure-like, sharp, shooting, stabbing.The pain was reported as a 10/10 on the pain scale, and intolerable which affected daily activities and interfered with sleep.This pain had been going on for more than a year.It was reported that this pain was reported as a sudden onset, constant, and nocturnal.The pain worsens with movement, and improves with opioids.The patient was also receiving ketamine injections, toradol injections, fentanyl patches and back injections.The hcp reported the patient has upper extremity paresthesia, upper extremity pain in the left arm and hand, weight loss, abdominal pain, urinary frequency, urinary urgency, bladder dysfunction, bowel dysfunction, saddle paresthesia, difficulty walking, joint pain (left side of pelvis and both knees).It was reported that the patient's neck pain affected the entire neck, and was described as achy, burning, and radiating to shoulders and both arms.The neck pain was rated as a 5-6/10 on the pain scale.The patient had been having neck pain for more than 1 year.The patient lower back pain was describes as burning, sharp, and radiating to the upper back.The pain was rated as a 10/10 on the pain scale and was unbearable, affecting daily activities, affecting sleep, and has worsened since onset.The patient had not been able to work since 2005 because of the pain.It was reported that this pain was reported as a sudden onset, constant, recurrent, and nocturnal.The lower back pain worsened with movement and improved with medication.The hcp reported the patient had claudication in both legs, and headaches.The patients leg pain was described as pain in the entirety of both legs.The pain was reported as burning, sharp, stabbing, more severe in the left leg, affecting daily activities, and affecting sleep.The pain radiates to the lumbar spine.The pain in the left leg was reported as a 10/10 on the pain scale, and an arteriogram of the right leg had helped improve the pain in the right leg.The leg pain had been occurring for more than 1 year.This pain was reported as worse in the morning, sudden onset, constant, worsening since 2005 helicopter crash, and occurs at rest.The leg pain worsened with movement, walking and bending.The leg pain improves with lying down and medication.The hcp reported that the patient had an edema in the legs that was tender to palpation.The hcp also reported limitation of movement, trouble standing, weakness, instability, limp, catching sensation, paresthesia in upper leg, hip pain, fatigue, prolonged ulcer on lower extremity, lower extremity skin discoloration, erectile dysfunction.It was reported that the patient experienced a decline in health, dizziness, head injury, blurry vision, double vision, eye pain, hair loss on legs, high blood pressure, sho rtness of breath, decreased appetite, excessive thirst, hemorrhoids, nausea, swallowing problems, diarrhea,vomiting, constipation, excessive hunger, heartburn, rectal pain, gout, excessive stress, nail appearance and texture change, tingling, memory loss, burning urination, urinary stones, incontinence, impotence, hernia, cervical spine tenderness, thoracic spine tenderness, and lumbar spine tenderness.No further complications were reported.Concomitant medications include; gralise 600mg tablet 1x/day, lidocaine 10mg/ml (1%) injection solution, soma 350mg tablet 2x/day, morphone 30mg tablet (2 tablets every 6 hours), testosterone cypionate 200mg/ml intramuscular kit, zoipidem 10mg tablet at bedtime when needed, duloxetine 30mg capsule (3 at bedtime), promethazine 25mg tablet (1 tablet every 6 hours), donepezil 10mg tablet (1 tablet nightly), lisinopril 10mg tablet 1x/day, ondanestron 8mg disintegrating tablet (1 tablet in the morning).
 
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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 Key9660761
MDR Text Key177597174
Report Number3004209178-2020-02427
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received02/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
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