Model Number 97800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Unspecified Infection (1930); Itching Sensation (1943); Insufficient Information (4580)
|
Event Date 03/01/2024 |
Event Type
Injury
|
Event Description
|
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and urinary dysfunction/sacral nerve stim.The reason for call was to report that last friday was diagnosed with an infection and patient received an antibiotic.Patient also said has bumps on their back that were really bad.Patient will be seeing managing physician tomorrow and said that it seems like the itching is a bit better.Patient mentioned that when checked the container of the antibiotic showed expired so patient will be receiving some additional antibiotic.Documented event, no further action taken by agent.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
Additional information was received from a healthcare professional (hcp).The hcp reported that the patient likely had an allergic reaction to the prep or glue that was used.They had antibiotics prescribed and the issue was resolved.
|
|
Event Description
|
Additional information was received from a healthcare professional (hcp).The hcp reported that the patient likely had an allergic reaction to the prep or glue that was used.They had antibiotics prescribed prophylactically and the issue was resolved.
|
|
Manufacturer Narrative
|
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Search Alerts/Recalls
|