MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
|
Back to Search Results |
|
Model Number 97715 |
Device Problems
Material Frayed (1262); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892)
|
Patient Problem
Burn(s) (1757)
|
Event Date 06/02/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Concomitant medical products: product id 97755.Serial# (b)(4).Product type recharger information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4).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 via manufacturer representative who was implanted with an implantable neurostimulator (ins) for other.It was reported that patient recharger wires broke and burned her on her back.Additional information was received from the patient rep.The reason for call was the patient rep (husband) reported the pt was recharging their neurostimulator (ins) battery a week or two ago when the recharger antenna (rtm) shorted out causing the pt to be shocked through their dress (caller noted that the pt recharges their ins every day).The caller stated one of the wires broke into leaving the pt with burns on their back.The caller described the burns as two little blue marks on the patients skin.The caller said they sent an email to their health care provider (hcp) to address the incident but they were forwarded contact information for a medtronic rep.The caller said they spoke to the rep over the phone yesterday or friday regarding issue.The caller said the pt was concerned their dress could have caught on fire and drafted an email explaining when the pt removed the apparatus (antenna) sparks were coming out of it and the rubber around the wires had caught on fire.Therefore, the device is no longer working making the pt unable to recharge their ins.The caller said they drafted an em ail along with a picture showing the burns will be sent be sent to the hcp and mdt rep to address the incident.A replacement rtm was sent to the patient.
|
|
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 patient rep orted that the replacement recharger telemetry module (rtm) resolved their issues with recharging and the rtm being hot.
|
|
Search Alerts/Recalls
|
|
|