MEDTRONIC EUROPE SARL COBALT¿ XT VR MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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Model Number DVPA2D4 |
Device Problems
High impedance (1291); Loose or Intermittent Connection (1371); Mechanical Problem (1384); Impedance Problem (2950)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/31/2023 |
Event Type
Injury
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Event Description
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It was reported that six weeks post implant, the right ventricular (rv) lead triggered alerts for high/undefined pacing impedance and high rv coil impedance.There were variable jumps in both impedances and r-waves had dropped post implant.Isometrics did not show any noise and normal impedances were noted.An implantable cardioverter defibrillator (icd) header/connection issue with a setscrew was suspected based on the time since implant or a possible rv coil fracture and ventricular fibrillation (vf) detections were turned off.A chest x-ray showed no obvious fracture nor an obvious set screw issue and that the rv lead pin appeared to be fully inserted into the header.The physician opened the icd pocket and observed that all connections seemed fine.In addition, the connections felt secure during a normal tug test.The physician also decided to rock the lead horizontally and felt a little rocking motion in the header and was not sure if that was normal.It could not be determined with certainty if the issue was with the lead or the icd, therefore, the icd system was explanted and replaced.No 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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Manufacturer Narrative
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Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.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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