MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
|
Back to Search Results |
|
Model Number 3058 |
Device Problem
Malposition of Device (2616)
|
Patient Problems
Anxiety (2328); Discomfort (2330); Insufficient Information (4580)
|
Event Date 10/21/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
B3: date is approximate.Month and year are confirmed valid.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.
|
|
Event Description
|
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that ever since they got the system implanted it protrudes and hits things and catches on the back of a chair if it has a low back.Patient said it is kind of bothersome and stays sore a good bit.Patient also mentioned that they have been having major bowel issues and are scared to leave the house.Patient has tried making adjustments to the system but they have not been able to resolve the issue.The patient was redirected to their healthcare provider to further address the issue and to get the system checked out.Patient service specialist reviewed role of representative and redirected them to their healthcare provider.
|
|
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 the patient.They reported that the cause of the implant protruding and catching on things was determined.The likely cause was listed as being "surgical placement of implant" and the steps taken/will be taken were noted as being "meeting with medtronic rep (b)(6) 2024." the issue was not yet resolved.
|
|
Search Alerts/Recalls
|
|
|