Model Number 6935M62 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); High Capture Threshold (3266)
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Patient Problems
Wound Dehiscence (1154); Atrial Fibrillation (1729); Bradycardia (1751); Purulent Discharge (1812); Unspecified Infection (1930)
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Event Date 03/10/2023 |
Event Type
Injury
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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 one month post-right ventricular (rv) lead revision, the patient had a small lateral pocket wound dehiscence with yellow purulent discharge from the wound.The cardiac resynchronization therapy defibrillator (crt-d) system was removed due to pocket infection.The patient was treated with antibiotics.The patient had atrial fibrillation (af) with bradycardia but was noted to be stable.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Correction: b1; b5; h6 device codes (fdd/annex a); imf (annex f) health impact code; img (annex g) component code.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.
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Event Description
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It was reported that one month post-right ventricular (rv) lead revision, the patient had a small lateral pocket wound dehiscence with yellow purulent discharge from the wound.The cardiac resynchronization therapy defibrillator (crt-d) system was removed due to pocket infection.The patient was treated with antibiotics.The patient had atrial fibrillation (af) with bradycardia but was noted to be stable.No further patient complications have been reported as a result of this event.Additional information received clarified that the rv lead revision was a procedure to reposition the lead due to high pacing thresholds.
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Search Alerts/Recalls
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