MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
|
Back to Search Results |
|
Model Number 97715 |
Device Problems
Material Frayed (1262); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Connection Problem (2900); Insufficient Information (3190)
|
Patient Problems
Burn(s) (1757); Burning Sensation (2146); Electric Shock (2554)
|
Event Date 12/20/2021 |
Event Type
malfunction
|
Event Description
|
Information was received from a patient (pt) regarding an external device.The reason for call was over a week ago the pts stimulator quit running for it had a short in it but then pt was able to get their implant to charge before it stopped again.The rtm had exposed wiring and when attempting to charge the implant and the pt had gotten a shock from the equipment a couple times.Pt noted that they burned their finger from the equipment.Pt noted the rtm did not work. patient states that their recharger has a exposed wire, that they tried to put electrical tape on, they had been burned twice, no specific date mentioned.They states that the burn is not bad, no blister, etc.States that they decided they better call. an email was sent to the repair department to replace the rtm.Pt noted they contacted their rep who told the pt to call and get a new rtm shipped out over night.
|
|
Manufacturer Narrative
|
Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger.Other relevant device(s) are: product id: 97755, serial/lot#: (b)(4), udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
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) who was implanted with an implantable neurostimulator (ins).The pt stated that the circumstances that led to the stimulator quitting, getting shocked, and being burned was that the recharger had a wire coming out of it.They reached back to see and got burned.The pt stated that the steps taken to resolve the issue was that they called medtronic and they sent the pt a new one.The pt stated that the issue has been resolved.
|
|
Manufacturer Narrative
|
H3: product id 97755; serial# (b)(6); was returned for product analysis; product was scrapped due to the device being frayed and causing telemetry issues during bench testing 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
|
|
|