Model Number 37612 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
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Patient Problem
Electric Shock (2554)
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Event Date 08/21/2021 |
Event Type
malfunction
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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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It was reported that the patient felt shock like feeling while walking 4 total times on her left side.2 of the times, she felt the shock down the left leg.Impedance check was performed on aug-23 showing all connections are within normal limits.They shared this report with the managing physicians.The issue was indicated as resolved.
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Event Description
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Additional information received, from the manufacturer¿s representative (rep).Which was confirmed, with the healthcare provider (hcp) reported, the cause of the shocking wasn¿t determined.The patient was scheduled to follow-up with the hcp in (b)(6) weeks.
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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 reiterating that the patient feels shocking/electricity in both hands when the impedance is tested at.7 volts, or when stimulation is on.They reported feeling the sensation when therapy wasn't being turning on or impedance check was done.They don't have a common body position when they felt the sensation.Impedances appear to be normal.Impedance values were as follows: (left c0) 2.55 volts 70usec 185 hz 0 862 ohms 1 639 2 671 3 760 0<(>&<)>1 891 2<(>&<)>0 1112 3<(>&<)>0 1280 3<(>&<)>1 1019 2<(>&<)>1 727 3<(>&<)>2 885 (right 8-9-10+) 4.2 volts 70usec 185hz 8 1008 ohms 9 862 10 844 11 1470 8<(>&<)>9 1209 10<(>&<)>8 1521 11<(>&<)>8 1985 11<(>&<)>9 1861 9 <(>&<)>10 1206 11<(>&<)>10 1580 ohms.
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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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Search Alerts/Recalls
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