MEDTRONIC NEUROMODULATION VERIFY; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
|
Back to Search Results |
|
Model Number 3531 |
Device Problems
High impedance (1291); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Human-Device Interface Problem (2949)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/05/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id: 3889, product type: lead.Other relevant device(s) are: product id: 3889, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a consumer regarding a trial patient who was using an external neurostimulator (ens) for urge incontinence.It was noted that the patient¿s trial started on (b)(6) 2020.It was reported that the procedure didn't work at first because one of the wires had come loose, so they had to go back into the procedure room and get it reinserted without anesthetic.The issue was noted to be resolved and no further patient complications are anticipated or expected as a result of this event.
|
|
Manufacturer Narrative
|
Concomitant medical products: product id 3889-28 lot# va24z0e serial# implanted: (b)(6) 2020.Explanted: product type lead 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.
|
|
Event Description
|
No new information.
|
|
Manufacturer Narrative
|
Concomitant medical products: product id 3889 lot# unknown serial# implanted: explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3889, serial/lot #: unknown, ubd: unknown, udi#: unknown h6: all codes present in this report are updated and correct.Please disregard previously submitted codes due to the additional information.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.
|
|
Event Description
|
Information was received from a healthcare provider via a manufacturer representative.It was noted that a rep was in a case with the healthcare provider doing a stage 1 procedure.It was reported that the impedances showed as high and they were unable to get the stimulation past.3ma.It was noted that the rep disconnected the twist lock and reconnected it, but the issue remained.It was reviewed that they could potentially replace the twist lock to see if it resolves, but the patient was already closed up and the healthcare provider gone, so they stated that they may be looking at a revision of the stage 1 procedure.No further patient complications are anticipated or expected as a result of this event.Additional information was received from a manufacturer¿s representative (rep) indicating that it was discovered that there was no malfunction in the equipment, the impedance problem and amplitude not able to be turned up post-op was an error by the healthcare provider.The lead was not inserted all the way into the extension wire hub.Af ter, discussing with the doctor, he brought the patient back into the operating room, opened up the pocket, retrieved the connection hub, and corrected the connection.Post-operatively the impedances were fine, and amplitude was able to be turned up normally.The patient had a successful advanced evaluation and was implanted on (b)(4) 2020.No further complications were reported.
|
|
Search Alerts/Recalls
|
|
|