Model Number 479888 |
Device Problems
High impedance (1291); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/11/2022 |
Event Type
malfunction
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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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Event Description
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It was reported that during implant of the left ventricular (lv) lead, at first fixation the thresholds were slightly high the physician decided to reposition the lead.At the second position, the threshold was similar.An attempt to unscrew the lv lead was made, but it was impossible to remove the lead, despite the guidewire was as distal as possible.The physician tried with the catheter advanced near to the screw to give more support, but still unable to remove the lead.Another attempt to remove the lv lead with the stylet was unsuccessful.The decision was made to keep the lead in place and retested the pacing threshold at 1.0 millisecond, the best threshold was 1.7 volts.After at the lead was connected to the device and in the pocket, all impedances with left vector 1 were very high and other impedances were in a normal range.The lv lead was programmed to left vector 3 to right ventricular coil whichhad the best threshold and impedance measurements.The lv lead remains in use.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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