MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97702 |
Device Problems
Insufficient Information (3190); Patient Device Interaction Problem (4001)
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Patient Problems
Apnea (1720); Pain (1994); Ambulation Difficulties (2544); Insufficient Information (4580)
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Event Date 09/08/2021 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.Pt reported they were implanted 2 days ago and they were upset because they feel as though they were "poorly taken care of".Pt stated they can feel stimulation in their legs but not their back.Pt stated they called mdt rep, carla and carla told pt it should be working in their back as well and told pt they hope they feel better and ended the conversation with pt.Pt stated they were upset with the fact that the rep didn't take what they were saying seriously.Pt stated they've been trying to get in contact with their doctor but have been unable to do so.Pt mentioned they have screws in their back.Pt also stated now they can hardly stand up to brush their teeth, they can't breathe, or walk.Pt mentioned they've had screws in their back.Pt also mentioned they take hydrocortisone so they can sleep.Pt also mentioned "it doesn't work when laying down" patient services (ps) understood this as stimulation doesn't work when laying down.Pt was requesting to speak with a "district sales manager" to report their frustrations with their experience.Ps emailed field reps for visibility.
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Manufacturer Narrative
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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.
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Event Description
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The rep reported that patient never had a trial and went straight to implant so it was unknown how pt was going to respond to stimulation.When patient left his initial programming coverage was bilateral.Patient was seen and reprogrammed on monday 9/13.Additional information was received from the patient.Pt stated that the ins is not working and needs to be reprogrammed at the hcp's office.Pt stated that their pain hasn't improved since getting implanted, and the programming currently provides stimulation in their legs when they need stimulation to cover their back.Pt noted the pain is just as bad as before the ins was implanted.Pt stated that they were referred to mdt through the va.Pt stated the ins "doesn't work all the time".Pt explained that the ins works when they lay down flat, but the ins doesn't work when they walk.Pt stated they can't turn the stimulation intensity up (when they are walking), because if they sit down, the stimulation causes the pt to "vibrate".Pss asked for an event date, but the pt just stated it was ar ound the time of being implanted (month/year valid).Pt reported a service complaint against the mdt reps, and reported the rep was made aware of the issue during this month (month/year valid).Pt stated to pss that they have retained a lawyer, and the hcp told the pt the ins needs to be reprogrammed or the ins will need to be taken out.Pss is forwarding a message to the field.
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Event Description
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Additional information was received.It was reported the cause was not determined.The patient was given further instruction on how to use the device and the issue has been resolved.
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Manufacturer Narrative
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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.
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