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); Inappropriate/Inadequate Shock/Stimulation (1574); Connection Problem (2900)
|
Patient Problems
Burn(s) (1757); Electric Shock (2554)
|
Event Date 01/27/2022 |
Event Type
malfunction
|
Event Description
|
Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that their recharger was getting so hot it was burning them (pt was not sure if it had been leaving a mark).Pt mentioned that the cord was also bubbling.An email was sent to the repair department to replace the recharger.
|
|
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), ubd: 28-oct-2019, udi#: (b)(4).Date of event: month and year valid.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Concomitant medical products: product id 97755, lot#/serial# (b)(6) product type recharger.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.It was reported the circumstances that led to the recharger hot and burning was it appeared that there was a small crack in the wiring where the paddle neck and wire meet which caused a short, which in turn caused the wire to get hot and burn/shock the patient's skin.The issue was resolved, the patient was sent a new paddle which completely resolved the problem.
|
|
Manufacturer Narrative
|
H3: product id 97755, serial# (b)(6), was returned for product analysis.Analysis found the complaint was unverified, the recharger telemetry module (rtm) never got hot after running for 10 minutes.No anomalies were visually observed on the rtm.The device was scrapped due to a t6030 failure (rms voltage at the h probe), there was a suspected recharge coil that was defective.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
|
See h10.
|
|
Search Alerts/Recalls
|
|
|