Model Number DTMB1D4 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Purulent Discharge (1812); Hematoma (1884); Unspecified Infection (1930); Fluid Discharge (2686); Pericardial Effusion (3271); Swelling/ Edema (4577)
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Event Date 06/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: 5076-45 lead implanted: (b)(6) 2018.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 cardiac resynchronization therapy defibrillator (crt-d) system was explanted due to an infection.It was noted that the incision site never healed. no further patient complications have been reported as a result of this event.
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Event Description
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Additional information received indicated the patient presented with pocket fluid drainage.It was also noted that a hematoma had occurred.A pre-operative transesophageal echocardiogram (tee) showed trace small pericardial effusion.The drainage required frequent dressing changes and did not resolve.Swelling was present and slowly improved despite the on-going drainage.During explant of the crt-d boggy purulent discharge was noted throughout the pocket.Post explant, the physician commented that the tee did not show any evidence of pericardial effusion.Hemostasis in the device pocket was confirmed.A 19 inch french blake drain was placed in the pocket and closure was performed.A temporary pacing system was implanted until subsequent new crt-d system was implanted.
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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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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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Additional information received indicated the patient presented with pocket fluid drainage.It was also noted that a hematoma had occurred.A pre-operative transesophageal echocardiogram (tee) showed trace small pericardial effusion.The drainage required frequent dressing changes and did not resolve.Swelling was present and slowly improved despite the on-going drainage.During explant of the crt-d boggy purulent discharge was noted throughout the pocket.Post explant, the physician commented that the tee did not show any evidence of pericardial effusion.Hemostasis in the device pocket was confirmed.A drain was placed in the pocket and closure was performed.A temporary pacing system was implanted until subsequent new crt-d system was implanted.
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Search Alerts/Recalls
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