MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
|
Back to Search Results |
|
Model Number 97715 |
Device Problems
Overheating of Device (1437); Delayed Charge Time (2586); Battery Problem (2885); Connection Problem (2900); Insufficient Information (3190)
|
Patient Problems
Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/23/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Concomitant medical products: product id: 97755 lot# : nlf050344n, product type: recharger.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4).Date of event: date is approximate.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins).It was reported that they were told to get a new recharger (rtm) by their manufacturer representatives (reps) as starting a couple weeks ago, the pt had noticed the paddle of the recharger (rtm) heating up.Pt mentioned the paddle kinda burnt their skin and confirmed it left a mark.Pt said the reps checked the rtm out and said there was a short in it.An email was sent to the repair department to replace the rtm.
|
|
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
|
Additional information was received from a patient (pt) regarding an external device.The patient stated that the circumstances that led to the recharger (rtm) burning their skin was that it was taking 1.5 hours to charge with the recharger.Without moving, it would give them an "m04" problem and they would have to disconnect and retry.The patient was asked if the replacement recharger resolved their issue.The patient stated that the issue was resolved and that their programming was changed and they only have to charge every 2-3 days as opposed to having to charge it every morning with the battery depleted when they would start charging.
|
|
Manufacturer Narrative
|
Concomitant medical products: product id 97755 lot#/serial# (b)(6), product type recharger h3.Analysis found there was a recharge antenna failure, no device found message.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
|
|
|