Model Number 694965 |
Device Problems
Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Defective Device (2588)
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Patient Problem
Emotional Changes (1831)
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Event Date 11/22/2009 |
Event Type
Injury
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Event Description
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A lawsuit alleged that the patient 'suffered physical and other injury as a result of the recalled lead'.It further alleges the patient has 'sustained and will continue to sustain severe physical injuries and/or death, severe emotional distress, mental anguish, economic losses and other damages.[patient] has suffered physical injuries and various physical manifestations of emotional distress'.Lead failure and defective lead also noted.It was further reported that the right ventricular (rv) lead was suspect of a fracture.The lead had oversensing of noise seen on high rate non-sustained episodes.The lead had sensing integrity counter (sic) episodes.The lead had high pacing impedance.The lead was capped and a new lead was implanted.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Concomitant medical products: ddmb1d1 icd implanted: (b)(6) 2019.The initial reported event of lead failure was previously submitted via a remedial action exemption (rae) summary report.The manufacturer has voluntarily discontinued this rae, so supplemental information is being submitted via a 30 day report.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 lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing associated with the right ventricular lead.Analysis of the device memory indicated the criteria for the right ventricular lead integrity alert were met.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.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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