MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
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Patient Problem
Electric Shock (2554)
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Event Type
malfunction
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Event Description
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The new device, patient is charging twice, in the morning and at night.Patient did not allege charging frequency issues.The replacement hcp¿s name was dr.(b)(6).Patient did not know the hcp¿s full name.Patient added that the new device zaps the patient.They clarified it is a shocking sensation.It is just one zap and then it is gone, it is when patient moves a certain way.Patient had called the rep yesterday to get the device reprogrammed but has not heard anything.Pt has an appt in on wednesday ((b)(6)) at 2:20 pm and will talk to the doctor and rep, if rep is present there.Patient said their weight is the same.
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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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Additional information was received from the patient who reported that the rep was called in who adjusted the settings for the patient.The patient reported they had no more shocking sensation, 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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