MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Ambient Temperature Problem (2878)
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Patient Problems
Discomfort (2330); Diaphoresis (2452); Alteration in Body Temperature (4568)
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Event Date 04/12/2022 |
Event Type
malfunction
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Event Description
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Information was received from a consumer regarding a patient receiving an unknown medication via an implanted pump.The indication for pump use was spinal pain.The patient reported that during an mri yesterday his pump started heating up to the point that he started sweating.It felt as if a large heating blanket had been placed over his pump on high.The longer the machine ran the hotter it got up until he was forced to have them stop the mri because the heat was radiating to other areas on his abdomen.Per the patient, he was only able to tolerate about half the mri scan due to the excessive heat.Once out of the machine, the heat dissipated in about 30 minutes and once he was home, he checked the pump and it appeared to be working normally.He stated the had multiple mris and this type of event had never happened to him before.
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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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Event Description
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Additional information was received that the patient's weight at the time of the mri was approximately 224 lbs.
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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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