MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395)
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Patient Problems
Abdominal Pain (1685); Emotional Changes (1831); Pain (1994); Malaise (2359); Weight Changes (2607); Insufficient Information (4580)
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Event Date 11/24/2022 |
Event Type
Injury
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Event Description
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Information was received from a patient representative regarding an implanted pump system for non-malignant pain.The pump was used to deliver unknown baclofen and an unknown drug.Dose and concentration information was not reported.It was reported that, for three months, the patient had been sick with stomach problems and had lost 30 pounds.The patient was initially told that it was not the pump.The patient's pump was recently replaced and it was discovered that there were four leaks in the catheter, so the patient had a catheter revision in addition to the pump replacement.The reporter was unable to recall on of the pump medications, but it was something similar to morphine.
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Manufacturer Narrative
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Concomitant medical products: product id 8731sc lot# serial# (b)(4) implanted: (b)(6) 2011 explanted: (b)(6) 2023 other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4) ubd: 13-nov-2012, udi#: (b)(4) 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 the patient who reported that they were just supposed to have the pump replaced because it popped out of the pocket, but they signed papers that if they found something else while in there that they would change out both pieces.Per the patient, they changed both because when they did the back, they found the catheter had 6 leaks.For 6 months prior, the patient had such bad stomach aches and they cried wondering why they couldn¿t eat and why they hurt so bad so they went to a digestive specialist who did testing, a ct scan, and everything trying to figure out why they couldn¿t eat and why they hurt so bad and couldn¿t figure out why, but it was not that, it was the pump/catheter.The patient¿s hcp (healthcare provider) said it was leaking a long time and the date was unknown.The pump was delivering baclofen at 110.65 mcg/day, dilaudid at 1.3619 mg/day, and fentanyl at an unknown dose.
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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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