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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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| Model Number 8637-40 |
| Device Problems
Filling Problem (1233); Obstruction of Flow (2423); Protective Measures Problem (3015); Insufficient Information (3190)
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| Patient Problems
Seizures (2063); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Sweating (2444); Shaking/Tremors (2515); Sleep Dysfunction (2517)
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| Event Date 09/06/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2012, product type: catheter.Product id: 85 96sc, serial#: (b)(4), implanted: (b)(6) 2012, product type: catheter.Product id: 8709, serial/lot #: (b)(4), ubd: 15-aug-2013, udi#: (b)(4); product id: 8596sc, serial/lot #: (b)(4), ubd: 03-nov-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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On 2020-mar-06, information was received from a family member of a patient receiving baclofen (2,000 mcg/ml, 619.1 mcg/day) via an implantable pump for intractable spasticity.It was reported the pump seemed to be working, but something was wrong.The caller reported the patient was tremoring once or twice in maybe the past 6 months or so, but she did not associate it with the pump.They were very slight and isolated occurrences, but last week, they became pronounced and ongoing.Last week, the patient had severe withdrawal.The caller initially thought the patient was having a seizure.The patient went to the emergency room (er).After a couple of nights of hospital stay, they thought the pump was working, but "suspect something [was] wrong in terms of connection".They did x-rays and the caller heard the healthcare professional (hcp) say something was blocking the catheter.The caller stated it was "something about catheter in the hub".They told her it was difficult to see the "connection" inside of the pump, it would not show on the x-ray.They "bolused' the catheter and caller thought the bolus actually unblocked whatever blockage the catheter was having.The patient seemed to be okay and went home, but after she came home, the patient still had been showing withdrawal symptoms (legs were jumpy, sweaty, shaking, tremoring).The caller stated, "this is week # 2 now".They were supplementing baclofen orally with a pill.The caller mentioned the pump was replaced in 2018, due to normal battery depletion but the catheter was not replaced, it was about 10 years old.The caller stated there was no alarm, but the patient has cerebral palsy and was non-verbal and could not tell if she heard any alarms.It was noted that when providing the drug information, the caller also read 25.8 mcg/hour.The patient was on the same mediation as 6 months ago.The caller stated they have been grateful for the pump and it has been working beautiful until symptoms became ongoing last week.
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Manufacturer Narrative
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Product id: 8709, serial# (b)(4), implanted: (b)(6) 2012, product type: catheter; product id: 85 96sc, serial# (b)(4), implanted: (b)(6) 2012.Product type: catheter.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the consumer on 2020-jul-09.It was reported that the patient is in a wheelchair and have convulsion at night.The hcp has done several tests and he would like to know what the options are for the patient, maybe the pump/catheter will need to be removed.Caller states patient takes oral baclofen which helps patient symptoms.Technical (ts) and patient services (ps) conferenced with the caller and discussed pertinent information regarding options for discontinuing therapy and reviewed having this conversation with the managing physician.Ts reviewed pump/catheter functions.Ts/ps recommend caller consult with the hcp office and call ts if necessary, or consult with a local rep.There were no further complications reported/anticipated.
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Manufacturer Narrative
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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.
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Event Description
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Additional information was received from a consumer on 2020-may-05.It was reported that the patient continued to go through severe baclofen withdrawals and was "losing confidence" in the hospital.Someone used to come to the patient's house for pump refills and if the patient could use that method, it was noted that they would be tighter but "won't have to go through the constant ups and downs of withdrawal and overdose.".
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Manufacturer Narrative
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Concomitant medical product: product id 8709 lot# serial#(b)(6) implanted: (b)(6) explanted: product type catheter product id 85 96sc 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.
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Event Description
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Information was received from the consumer regarding the implantable drug infusion device.The drug being delivered was 2,000 mcg/ml lioersal (baclofen) at 619.1 mcg/day.It was reported that the patient has had ¿problems with the tube or the connection.¿ the patient had gone through a withdrawal and the healthcare professional (hcp) had tried pulling out medications with tube and were not able to.Caller first stated (b)(6), 2020 this started, but later in the call they reported that on (b)(6) patient had an incident when had gone to the er.On (b)(6) 2020 , the patient had hard time sleeping, very restless, and all of a sudden patient vomited and had a large bowel movement, and the patient was shaking.Caller states they thought it was maybe a seizure so gave oral biazatime 10mg, but still the body was shaking.They had gone so many years with no issues, so they tried giving baclofen and gave 10mg before going to the er.6 hours later they had given 10 more mg of baclofen in the er because nobody had come to see them.That calmed down the patient.That night, a surgeon came in was told to not mess with the pump and she tried to use syringe and pull fluid out of pump and couldn't pull any but thought she had set pump to replenish what was taken out and had given patient 300 or half of a daily dose over 30 minutes, then the er doctor couldn't do anything, so they stayed a night and had to give oxygen to keep the patient going.Caller states they did a dye study and had to wait a week and with all the covid, couldn't get anything back.The doctor stated the test showed normal.¿sometimes have to replace connector, dye study was just showing the tube and that was a week ago and just found out two days ago that didn't show anything.¿ caller states they are checking for leak around the connector.The caller was to follow up with the hcp.There were no further complications reported/anticipated.
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