MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problems
Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)
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Patient Problems
Burning Sensation (2146); Electric Shock (2554)
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Event Date 09/29/2022 |
Event Type
malfunction
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Event Description
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It was reported that the patient claimed to have a mild shocking/buzzing sensation down right side of body while charging her device.She also claims that the area around the device gets very warm while charging.No falls or external factors were reported.The patient and husband were instructed to change charging speed and it seemed to be better but the shocking/buzzing was still there, and the heat was less.The hcp performed impedances and they were normal.Programming is in bipolar mode on both sides.When the patient reduced the charging speed to #2, it seemed to help but symptoms still persisted during charging.The issue was not resolved.The physician and patient want to try replacing the wireless recharger to see if that helps.
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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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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 manufacturer¿s representative (rep) reported the cause of the shocking or buzzing sensation wasn¿t determined.The consumer noted that it did not occur while charging in an upright position and they used a special belt and upright chair to facilitate this which worked well.The consumer now charged with no shocking or buzzing sensation.
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