MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
|
Back to Search Results |
|
Model Number 97715 |
Device Problems
Intermittent Continuity (1121); Failure to Deliver Energy (1211); Battery Problem (2885)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
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.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 who was implanted with an implantable neurostimulator (ins).The reason for call was caller stated that for the past at least 6-8 months their stimulation will turn off randomly.Caller statedthat after they finish recharging their implant, they will set the controller down and not touch it.Caller stated they will grab it a couple days later and it will stay stimulation off and the battery will be at 50%; caller stated that both the controller and implant will be at 50% but also stated they won't be able to see the implant battery.Caller informed mdt rep amy wise of this issue on (b)(6) 2022 and was told to call patient services for a replacement controller.Agent reviewed that stimulation will turn off if the implant drops below 20% battery and should not be turning off unprompted.The caller was redirected to their healthcare provider/ field rep to have the implant interrogated.Redirected caller: patient's hcp rep confirmed they did not see the patient or remember this patient.
|
|
Manufacturer Narrative
|
Continuation of d10: product id: 97745bp, serial# (b)(6), product type: accessory; product id: 97745, 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 was received from the rep.Rep called and was with pt at the time of call.Pt stated that their controller and ins will be charged to 100% and their controller reads that stimulation is turned off, but the ins depletes to 60%.Rep interrogated the ins with their tablet and the stimulation usage report did not show 'therapy unavailable' at any point in time indicating that the ins would have been depleted.Pt also stated that they controller becomes unresponsive.A replacement controller and battery pack were requested.
|
|
Search Alerts/Recalls
|
|
|