Model Number 37612 |
Device Problems
High impedance (1291); Low impedance (2285)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
Injury
|
Manufacturer Narrative
|
B3: event date is not known.Please see b5 for approximate date range, if applicable.Section d references the main component of the system.Other medical products in use during the event include: brand name activa; product id 3387s-40 (lot: va1srdp); product type: 0200-lead; implant date (b)(6) 2018.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.
|
|
Event Description
|
The manufacturer representative (rep) reported patient (pt) had lead revision done today.Pt was implanted with a sensight lead.Right side was revised. pt had impedance issue, asked unknown when the impedance issue started, caller reports she was notified today of the revision.Caller reports she is seeing the charge density warning.Caller reports patient is programmed:c+1- 2.5v/90pw/135hz.C1: 848 ohms.Caller reports all impedance are within normal limits.Low impedance value: 0/3: 1477 ohms, high impedance value: 1a/2c: 4120 ohms.Reviewed charge density.No symptoms reported.
|
|
Manufacturer Narrative
|
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
|
Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the cause of the impedance issue was due to the lead as it was resolved with a lead revision.
|
|
Search Alerts/Recalls
|
|