MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
|
Back to Search Results |
|
Model Number 97715 |
Device Problems
Failure to Deliver Energy (1211); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Material Deformation (2976); Insufficient Information (3190)
|
Patient Problems
Device Overstimulation of Tissue (1991); Numbness (2415); Electric Shock (2554)
|
Event Type
malfunction
|
Event Description
|
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the ins has not been working right for "awhile" pt clarified longer than 6 mos.Pt stated it feels like the wire is twisted in her right arm in the past week pt stated the ins is implanted in the chest area pt stated when she turns stim on there is too much power in her right hand and it feels like she has her finger in a light socket and she can't get it out.Pt moved and she does not have a current hcp.The patient was redirected to their healthcare provider to further address the issue.Pss is sending an fyi message to the local field reps about pt call.
|
|
Manufacturer Narrative
|
Concomitant medical products: product id 977c265 lot# serial# (b)(4) product type lead other relevant device(s) are: product id: 977c265, serial/lot #: (b)(4), ubd: 20-dec-2021, 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
|
Additional information was received from a patient (pt).It was reported that the pt requested a name or someone to come out to check out their device to make sure the wires were still connected.Pt denied any falls/trauma.Pt explained the leads were implanted in their right arm.Pt mentioned their healthcare provider (hcp)tried to hook them up with an orthopedic doctor but they only work with pt who have the spinal cord stimulator (scs) in the back.Pt claimed they had not had the scs ins therapy on for 1-1.5 years because of the shocking sensation.Pt stated they had nerve damage from a chainsaw accident and there hand is no longer functioning from not getting any stimulation.Pt said they were unable to pick up objects without looking at it because of no feeling in the hand.Patient registration shows pt residing in south carolina.Patient services (pss) is going tohave to follow up with pt next busines s day to clarify what territory they are living in order to send email request to correct field representatives.
|
|
Manufacturer Narrative
|
Continuation of d10: product id: 977c265, serial# (b)(6), and product type: lead.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
|
|
|