MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
|
Back to Search Results |
|
Model Number 3058 |
Device Problems
Unintended Collision (1429); Battery Problem (2885); Electromagnetic Compatibility Problem (2927)
|
Patient Problem
Incontinence (1928)
|
Event Type
malfunction
|
Event Description
|
Information was received from a patient regarding an implantable neurostimulator for the treatment of bladder issues it was reported that in the last two weeks, their symptoms have been really bad; however, patients couldn't remember when they first experienced a return of symptoms.The patient said that when they stand up, they are soaked to their knees. the patient said that they did have a fall around christmas.The patient connected earlier today and received a message that "the internal device has lost all data." when asked, the patient said that they had had several medical tests and procedures in the past few months.I reviewed the meaning of the message, and that requires a reprogramming session at the physician's office.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.
|
|
Manufacturer Narrative
|
B3: event date is not known.Please see b5 for approximate date range, if applicable.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
|
This event is no longer a reportable event.Mdr decision corrected to not reportable.No additional supplemental mdrs are required unless additional information received makes the event reportable.Due to gch functionality, the complaint flag cannot be flipped to "no" as a regulatory report exists in this pe.
|
|
Manufacturer Narrative
|
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefor this event does not meet the reporting requirements stipulated in 21 cfr 803.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
|
|
|