MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
|
Back to Search Results |
|
Model Number 37612 |
Device Problems
Failure to Deliver Energy (1211); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Communication or Transmission Problem (2896)
|
Patient Problem
Electric Shock (2554)
|
Event Type
malfunction
|
Event Description
|
The patient reported that about a year and a half ago they fell down a flight of stairs.The patient did not indicate that the fall was related to the device/therapy, but when they fell they thought they hit their chest about as much as they hit their head.Immediately after the fall, the patient felt an intermittent shocking sensation, which made them think the ins was "shorting out." the patient stated that they experienced the intermittent shocking sensation for several months.The patient reported the issue to their doctor, but the doctor could not find anything wrong with the ins.The patient said they were no longer experiencing the intermittent shocking sensation at the time of the call.However, about 2-3 weeks ago, the patient noticed that their patient programmer suddenly was not communicating with their ins and they were getting the 'poor communication' screen.The patient confirmed that they were still able to charge their ins with their recharger, but they noticed that sometimes they could not get good coupling.During the call, the patient continued to get the 'poor communication' screen on their patient programmer.The patient does not use an antenna with their patient programmer, and they confirmed they had the patient programmer over their ins.The patient started to charge their ins and had excellent coupling (all 8 coupling bars filled in), and the ins was between 0-25% charged.The patient noticed that their ins was turned off as well, which they attributed to the low ins charge level.An email was sent to the repair department to replace the patient programmer.Agent reviewed that the patient will be able to turn the ins back on with the replacement patient programmer as long as the ins battery has a sufficient charge.The patient was advised to call back if they require further assistance.
|
|
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.
|
|
Manufacturer Narrative
|
H3.Analysis of the patient programmer (s/n (b)(6)) found the spring in the battery compartment were corroded.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
|
|
|