Model Number PACLGK02 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Fistula (1862); Pain (1994); Tissue Damage (2104); No Code Available (3191)
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Event Date 07/05/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, 4 years post-operative of a laparoscopic procedure, the patient needed medical or surgical intervention to prevent a permanent impairment of a function due to a device issue.The patient¿s hospitalization was extended for a week.There was tissue loss and fistula as a result of the issue and that there is a permanent damage.The incision was also extended for more than 1 inch (2.54cm).The surgical time was extended for 30 minutes or more due to the product problem.There will also be an additional operation performed to correct the issue.
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Manufacturer Narrative
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Additional information: patient code-c64343(surgical intervention required, extended hospital stay, tissue loss).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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According to the reporter, 4 years post-operatively of a laparoscopic procedure for prolapse, the patient had pelvic pain, fistula, vaginal pain, and vaginal and rectal erosion.Re-intervention was required to prevent permanent impairment of a function and the patient underwent mesh ablation and plate removal with biological repair.The patient was hospitalized for a week.There was tissue loss, and permanent tissue damage as a result.The incision was also extended for more than 1 inch (2.54cm).An additional operation will be performed to correct the issue.
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Search Alerts/Recalls
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