MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
|
Back to Search Results |
|
Model Number 37612 |
Device Problem
Failure to Deliver Energy (1211)
|
Patient Problems
Irritability (2421); Ambulation Difficulties (2544); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
malfunction
|
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.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
|
It was reported that patient has not been acting like himself today, has not gotten out of bed all day, or eaten anything.We checked the implantable neurostimulator (ins) status and the ins was off.Instructed caller to turn on ins, the patient became agitated.Requested the caller turn ins off and to contact managing healthcare provider (hcp) for direction.Caller does not know how long patient the patient ins has been turned off requested caller reach out to managing hcp as soon as possible to get advice on next steps.If caller needs assistance on turning amplitude down, then to call a technical support specialist back.Caller wanted to review insr screen, the description discussed was a fully charged ins.
|
|
Manufacturer Narrative
|
Section d information references the main component of the system.Other relevant device(s) are: product id 37642; serial# (b)(6); product type programmer, patient.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 received from the consumer reported the patient wasn't acting quite like themselves and they weren't sure if therapy was working or not.The consumer tried connecting with the programmer (without the antenna) and got poor communication/no connection.The recharger was used to connect which showed stimulation was off with the implant being fully charged.The implant/stimulation was turned on.
|
|
Search Alerts/Recalls
|
|
|