MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97714 |
Device Problem
Overheating of Device (1437)
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Patient Problems
Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2022 |
Event Type
malfunction
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Event Description
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Information was received from a patient (pt) regarding an external device to an implantable neurostimulator (ins).It was reported that the patient was getting poor communication message on the patient programmer with and without the antenna cord since 3-4 days ago and they were not able to adjust stimulation.The patient reported they noticed they were feeling heat on the incision area 3-4 days ago when the patient programmer was over the ins area.The patient stated they are able to charge up the ins with the recharger just fine.The manufacturer's patient services specialist (pss) asked the patient to remove the batteries from the patient programmer and inspect for corrosion and the patient said there was no damage, they saw dirt inside the patient programmer yesterday and cleaned it out.Pss confirmed the patient did not have a fall or trauma.The patient stated they fell on their knee but nothing major.The patient stated they had replaced the batteries and was still getting the poor communication message.The issue was not resolved.A replacement patient programmer was sent out.
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Manufacturer Narrative
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Concomitant medical products: product id: 97740, serial#: (b)(4), product type: programmer, patient.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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Continuation of d10: product id: 97740, serial# (b)(6), product type: programmer, patient.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, it was reported the new controller resolved the problem.
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