MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Filling Problem (1233); Migration or Expulsion of Device (1395)
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Patient Problems
Headache (1880); Muscular Rigidity (1968); Undesired Nerve Stimulation (1980); Pain (1994); Ambulation Difficulties (2544); Insufficient Information (4580)
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Event Date 10/18/2022 |
Event Type
Injury
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Event Description
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Information was received from the consumer (con) regarding a patient receiving baclofen via an implanted pump.The indication for use was intractable spasticity, spinal cord injury, and spinal cord disease.The patient reported that they have been having medical issues, and the doctor gave them "too much baclofen".The patient stated they had to go to a nursing home for three months.The patient stated their legs "froze".The patient stated this pump "hangs out" on their side.The patient stated when they are sitting up they feel something wrong with their "good leg", like a nerve is being pressed in their legs.The patient was also experiencing severe headaches.The patient spoke with the managing hcp who told them to go back to the surgeon.The surgeon said they could not do anything, and they should speak with a "neurophysicist" to learn how to how to live with it.The patient stated they are in pain and believes there was something really wrong.
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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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Manufacturer Narrative
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H3.Device code a0104 is not applicable to this event.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 received from the patient indicated that they talked with the surgeon and they told the patient that they'd "have to live with that".It was again reported that the pump was "hanging out the side of my stomach".Per the patient, they'd "had the pump for a while, you can feel the whole thing and i never used to feel it".The surgeon stated that "it could be scar tissue but that 'i couldn't put it in'".Per the patient, "it must be hitting a nerve on my leg because my butt on that one side and i'm in a lot of pain".From the waist down, "maybe 2-3 inches, you can feel it - you feel the whole thing".The patient "used to not feel it and go home the next day feeling great".Per the patient, "that didn't happen this time and i can hardly stand up".The patient could not drive any more.The patient's healthcare provider (hcp) told the patient to go to a surgeon.Per the patient, while they were in a nursing home, sometime after the pump was replaced, they were given "70 of baclofen" and the patient couldn't move their arms or turn side to side.The patient was "frozen".The patient would "usually get 55 every time i had it filled but she gave me 70, so they started dropping me down by two points each and now i'm at 58 or 55 and that's okay".The patient was redirected to their healthcare provider.Physician listings were sent to the patient.
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