Model Number 407652 |
Device Problems
Failure to Capture (1081); Over-Sensing (1438); Device Contamination with Body Fluid (2317); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
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Patient Problem
Bradycardia (1751)
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Event Date 03/15/2022 |
Event Type
Injury
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Manufacturer Narrative
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The full lead was returned and analyzed.Analysis indicated the outer insulation of the lead was extrinsically breached due to a cut.There was blood on the proximal conductor of the lead and it was not obstructed.Visual analysis of the lead indicated apparent explant damage.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 experienced bradycardia.It was noted that the right atrial (ra) lead and right ventricular (rv) lead dislodged.High and rising thresholds, undersensing, inappropriate sensing and pacing spikes were also observed on the rv lead.No capture, high thresholds, crosstalk, inappropriate sensing and insulation damage were noted on the ra lead.Due to high outputs on the pacing leads, the implantable pulse generator (ipg) experienced faster than expected battery depletion.The rv lead was initially reprogrammed and the ipg system was explanted and replaced.No further patient complications have been reported as a result of this event.
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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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