Model Number 37800 |
Device Problems
Degraded (1153); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)
|
Patient Problems
Therapeutic Effects, Unexpected (2099); Electric Shock (2554)
|
Event Date 07/30/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id: 4351-35, serial#: unknown, implanted: (b)(6) 2014, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: unknown, ubd: 08-apr-2016.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the hcp interrogated the device the week prior to the report and found that c <(>&<)> 2 was reading 14,238, c <(>&<)> 3 was reading 434, and 2 <(>&<)> 3 was greater than 20,000.The hcp was thinking it may have been an eroded lead causing the issue.They planned on getting an endoscopy to check for erosion.It was also noted that the patient had never done well with symptom relief.The hcp stated they might suggest having it removed, but nothing was scheduled and nothing was done at the time of the report.No further complications were reported or anticipated.
|
|
Manufacturer Narrative
|
Product id: 4351-35, serial# unknown, implanted: (b)(6) 2014, product type: lead.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Additional information was received from the manufacturer representative (rep).It was reported that the hcp opened up the pocket on the day of the report and unscrewed the leads, then screwed them back in.Impedance was around 620 ohms.He checked c<(>&<)>2 and c<(>&<)>3 as well and they returned to normal.This should have corrected the issue.They assumed it was a set screw issue.No patient complications were reported as a result of this event.
|
|
Event Description
|
Additional information received from a healthcare professional (hcp) via a manufacturer representative (rep).It was reported that they turned the device off, but the patient was still getting a shocking sensation.On (b)(6), it was reported the hcp saw the patient on (b)(6) and they had the same impedance issue.They noted they may replace the lead in (b)(6) [2020].
|
|
Manufacturer Narrative
|
Continuation of d11: product id 4351-35 lot# serial# unknown implanted: (b)(6) 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.
|
|
Search Alerts/Recalls
|
|