MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
|
Back to Search Results |
|
Model Number 97800 |
Device Problems
Electromagnetic Interference (1194); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Loss of Data (2903); Data Problem (3196)
|
Patient Problems
Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Discomfort (2330)
|
Event Date 04/18/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
B3: date is estimated; month and year are 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.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.The reason for call was patient had a brain mri two weeks ago and put device in mri mode.Patient went to turn therapy back on and it didn't go back to the program they were on.Whatever setting it was on prior was gone.Patient turned on the therapy but doesn't even know what program they on.It came up as program 3 at 0.0.Patient thought they were at two point something before.Patient increased the stimulation to 1.8 and it was uncomfortable.Patient was feeling the stimulation in the vaginal area instead of where they usually feels the stimulation in the back area.It happened once before when they were on the wrong program.Patient went and had a urine test and it came back just fine.Patient said, they had a big blow out after the mri.Currently the patient is at 1.6 they had to decrease it because 1.8 was too much.Told patient some times when you go back to your settings after it has been off it feel like too much.Helped patient increase to 1.7 and it was comfortable.Confirmed stimulation in bicycle seat area and comfortable.Patient will maintain stimulation level and will continue to track symptoms.
|
|
Event Description
|
Additional information was received from the patient.They reported that they had a doctors appointment on (b)(6) 2023 and they saw a manufacturing representative there.They gave no clarification, but they did confirm that the issue has been resolved.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|