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 Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/03/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Continuation of d10: product id tm90d0 (serial: unknown); product type: 0001-accessory; 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
|
Information was received from a patient regarding an external device.Caller reported that the communicator is not holding a charge.Caller stated that she leaves it plugged in all the time and it will only go to 15%.The caller stated that the tm90 will flash green, but when they try to check the implantable neurostimulator (ins) will flash yellow.The caller stated that they can't connect to the dbs therapy app to check the ins due to the tm90 battery issue.Caller states she has tried different outlets and has also tried a different plug.Caller stated that she went to see her healthcare provider today and was told that her therapy has been off since february 24th.Caller confirmed that she is able to charge her implanted neurostimulator.The issue was not resolved through troubleshooting.An email was sent to the repair department to replace the tm90.See rtg0528534 for mention of previous case.
|
|
Event Description
|
Additional information received from the consumer reported the cause of therapy being off was due to the external device and them needing a new one.The patient said they were going to be getting a new doctor as their products kept dying and they don¿t realize it because they don¿t check it every day.
|
|
Manufacturer Narrative
|
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
|
|
|