MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
|
Back to Search Results |
|
Model Number B35200 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
|
Patient Problem
Electric Shock (2554)
|
Event Date 03/02/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that patient experienced a shocking sensation on "right side." subsequent conversations with patient, son, and daughter-in-law revealed the sensation was in lips and right hand.This was reported after patient had a battery replacement on (b)(6) 2024.Doctor had patient turn off system temporarily.Shocking sensation subsided while implantable neurostimulator (ins) was off.After turning back on again, doctor had patient put device into mri mode to run an impedance check and mri mode was successful.Doctor provided instructions to the son and daughter-in-law on how to decrease stimulation using the handheld remote. patient's family decreased stimulation from 5.0ma to 4.7ma and patient indicated she "felt better." doctor advised them to continue to lower stimulation as needed if the sensation reoccurs.Also advised patient to setup an appointment with her neurologist.Neurologist reported that she saw patient on (b)(6) 2024. she adjusted her dbs settings and the issue appeared to be resolved.No further follow up was needed, per provider.
|
|
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
|
|
|