MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37601 |
Device Problems
Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
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Patient Problems
Undesired Nerve Stimulation (1980); Electric Shock (2554)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 3387s-40, lot#: va0jhdm, implanted: (b)(6) 2015, product type: lead.Product id: 3387s-40, lot#: va0p59t, implanted: (b)(6) 2015, product type: lead.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2015, product type: extension.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 11-mar-2017, udi#: (b)(4); product id: 3387s-40, serial/lot #: (b)(4), ubd: 05-aug-2017, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 16-sep-2018, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 16-sep-2018, udi#: (b)(4).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 had a shocking sensation shooting from ipg up left neck, down back, left arm and left leg and when turning head toward right.¿xray were taken.Notes from radiologist: "status post bilateral frontal deep brain wire lead placement.Leads appear continued on the ap view.Potential projectional lead interruption or kinking on the lateral view at the skull vertex.Ct would offer more complete evaluation of this region.Multilevel degenerative changes in the included cervical spine." the issue was not resolved.
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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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The cause was unknown.The neurosurgeon took a ct scan and was waiting on the results.They are planning to explore and possibly revise the patient's dbs system, tentatively scheduled for march 25th.
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Event Description
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Additional information received from the manufacturer¿s representative (rep) reported the patient underwent surgery on (b)(6) for intermittent shocking in the neurostimulator pocket when ¿yawning, turning their head, and sleeping on the left side.¿ pre-operatively impedances were normally bilaterally.The rep attempted independent left versus right ¿off¿ and subsequent ¿on¿ first with left, then right to try and narrow down shocking to a specific side, but it was unsuccessful as shocking was present with stimulation on bilaterally.Intra-operatively an alligator clip was used to test the extension with impedances normal bilaterally.A twist lock was used to test the leads and impedances were normal bilaterally.The physician removed both extensions, tunneled new extensions, and reconnected the existing leads and new implant with impedances being normal bilaterally.Post-0eropatively stimulation was turned off and then on to test for shocking and there was no shocking reported even when the patient turned their head side to side with impedances remaining normal bilaterally.
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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.
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Manufacturer Narrative
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H3.Analysis of the ins (s/n (b)(6) ) found no significant anomaly.Analysis of the extension (s/n (b)(6) ) found no significant anomaly.Analysis of the extension (s/n (b)(6) ) found no significant anomaly.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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