MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
|
Back to Search Results |
|
Model Number 3058 |
Device Problem
Therapy Delivered to Incorrect Body Area (1508)
|
Patient Problems
Undesired Nerve Stimulation (1980); Urinary Frequency (2275); Insufficient Information (4580)
|
Event Date 06/19/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.It was reported that the patient reported their current stimulator never worked to resolve symptoms.They stated they felt it more in the rectum, was making them go to the bathroom, and more working like something with intestines.They tried changing to different programs, including program a, but decided to turn stimulation off.They also mentioned they feel the stimulation may have shifted.Agent did not ask about the circumstances that led to the reported issue.Troubleshooting was unable to be performed as the patient wanted to keep stimulation off.They have a head mri later today and need stimulation off.No further complications were reported.
|
|
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.
|
|
Event Description
|
Additional information was received from the patient.They reported that the cause of the stimulation output issue was determined to be no error.They said the patient services agent walked them through steps to turn the device off for mri.
|
|
Search Alerts/Recalls
|
|
|