Model Number 37601 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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Other applicable components are: product id: 3708660, serial# (b)(4), product type: extension; product id: 3708660, serial# (b)(4), product type: extension.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 24-jul-2018, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 05-nov-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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Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for dystonia, movement disorders.It was reported that the patient had their ins replaced due to normal battery depletion, but since their replacement they felt as though their ins was sitting lower and the wire was a lot tighter than it was before.The patient stated the device seemed to have shifted.The patient had spoken to the hcp who agreed it was far too tight and needed to be looked at.The patient said the hcp called into the surgeon but had yet to get a response.The patient inquired what other steps they could do.The patient said they would try to use tape to hold up the ins for now.There were no further complications reported.
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Manufacturer Narrative
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Section 'device' information references the main component of the system and other applicable components are: product id: 3387s-40, lot# va0p406, product type: lead; product id: 3387s-40, lot# va0psrb, product type: lead.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 that the patient called back repeating the same information already in the original call notes.They stated that the surgeon told the patient to pull on the already tight lead wire to ¿stretch it out,¿ but the patient did not feel good about that and was advised to discuss further with their doctor.It was later received that the patient had a revision surgery planned for next month to fix the lead wire.There were no further complications reported.
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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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