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Model Number 693165 |
Device Problems
Fracture (1260); High impedance (1291); Over-Sensing (1438)
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Patient Problems
Anxiety (2328); Distress (2329); Depression (2361)
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Event Type
Injury
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Manufacturer Narrative
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The initial reported event of apparent fracture and cap/replacement of the rv lead was previously submitted via remedial action exemption (rae) summary report.The manufacturer has voluntarily discontinued the rae, so supplemental information is being submitted via a 30 day 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 the lead had an apparent fracture, oversensing, and the lead integrity alert triggered.The lead was capped and another lead was implanted.No patient complications were reported as a result of this event.On 2018-05-16 further information indicated that the patient is part of a lawsuit alleging that the lead is inherently defective and that the patient may have suffered damages and losses including, but not limited to: emotional distress, including mental distress, anger, depression and anxiety.It was further reported that the right ventricular (rv) lead also exhibited increased impedance and elevated sensing integrity counter (sic).It was difficult to explant the lead so the high voltage portion of the lead was capped and the pace/sense portion of the lead remains in use.On 2020-12-09: it was further reported the rv lead was explanted several years later.
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Event Description
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It was further reported the rv lead was fully capped during a system downgrade and then explanted a year later.
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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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