MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Pain (1994); Distress (2329)
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Event Date 08/21/2020 |
Event Type
Injury
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Event Description
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Information was received from a consumer regarding a patient receiving baclofen via an implanted pump.The patient's medical history included the patient having 33 surgeries in the past due to his medical conditions; cerebral palsy; and hydrocephalus requiring a brain shunt that had since been removed.The indication for pump use was intractable spasticity.It was reported that since implant, the patient¿s pump had not been secured in place and had been moving around in the patient¿s body.Per the reporter, the patient had cp (cerebral palsy) and had to get into the tub on his knees and easing over the side of the tubhit the pump and moved it way down and this drove the patient crazy.The patient couldn¿t bend over without the pump being in the way.They had spoken to the surgeon who recommended that the patient put a binder on for a couple of weeks until it stuck in place.With previous pumps they put mesh around the pump, but that wasn¿t done with this pump.The reporter was wondering if there was any risk to the pump and catheter if the pump was moving around like it was.Per the reporter, the patient had an appointment with his hcp (healthcare provider) this week and they wanted to have as much information as they could prior to that appointment.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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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 received from the healthcare provider reported that the pump will be relocated to a new site.The current pump will still be used in the revision.
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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 indicated the patient¿s pump was not secure and moves around.It was noted it caused pain to the patient.
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Search Alerts/Recalls
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