MEDTRONIC EUROPE SARL VIVA¿ XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTBA2D4 |
Device Problems
Misconnection (1399); Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/25/2023 |
Event Type
malfunction
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Event Description
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It was reported that several alerts were triggered for the right ventricular (rv) lead due to high rv coil impedance rising above the alert threshold, as well as variable rv coil impedance per the trends.The alert was cleared.Eleven days later, another alert was triggered for high/undefined rv pacing impedances.A possible connection issue or fracture was suspected.The rv lead and cardiac resynchronization therapy defibrillator (crt-d) remain in use. no patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Continuation of d10: product id 6935m62 lot# serial# (b)(6) implanted: (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.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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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 further reported that there was a slight deterioration in patient health status and that the right ventricular (rv) lead was suspected to be fractured.The rv lead was explanted and replaced.Additionally, the physician believed that they were missing an alert notification from the device to the clinic when the high pacing impedance out of range occurred and instead they only noticed it later in the observations of the interrogation report.Device programming for impedance alerts were explained as the device was functioning as programmed.The device remains in use.
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Manufacturer Narrative
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Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated an alert.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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