MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)
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Patient Problems
Headache (1880); Muscular Rigidity (1968); Discomfort (2330); Electric Shock (2554); Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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It was reported that when the patient had a blow dryer out, they felt kind of like their nerves and muscles were tightening where their muscles and face were being pulled and that they were a little tender right around the incision area and as ins was in the abdomen, was near their groin area.The caller stated it was the same feeling they felt when the dbs was first turned on after being implanted, and the doctor had to adjust the programming to resolve it.Additional information was received that the patient's neurologist checked "the wires and everything" with their equipment yesterday on (b)(6) 2022 and said that everything seemed to be fine with the implanted components from their perspective.The patient repeated information regarding the surge they felt down the top of their leg and muscles tightening when the blow dryer was on.The patient said they reported this to their neurologist yesterday, and they told the patient there were "all good readings on the wires" and told the patient to have the manufacturer company call them if they would like to discuss this further.
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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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H6.Update/correction: patient code: e2104 and e0116 and device code: a071302 are also 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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It was reported by the patient that stopping using the blow dryer in a seated position resolved the issue.It was also confirmed that the symptoms were resolved.
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Search Alerts/Recalls
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