MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problems
Unintended Collision (1429); Battery Problem (2885)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/01/2022 |
Event Type
malfunction
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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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It was reported that after the patient fell on friday, they noticed a change in their symptoms.The caller said patient normally charges on tuesdays but thought they would recharge on saturday to full, but noticed no change in their symptoms.The patient said they used the handheld 37642 and when they did, they saw por and a picture of a doctor.Caller also reported the patient got a life alert necklace in case they fell and wondered if that could have caused por.Reviewed por meaning and redirected to the doctor to have the system checked in person.The issue was not 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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Event Description
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Additional information was received from the hcp.Caller stated that the patient saw a por message on the patient programmer.The patient reported having a significant change in symptom control so that prompted the patient to check the ins with the patient remote.The caller indicated that they interrogated the device and it displayed a por message.The issue was not resolved through troubleshooting.During the call the caller turned stim on and ended the clinician programmer session.The caller confirmed that the patient was able to interrogate the ins using the patient controller and the device did not display an error message.
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Search Alerts/Recalls
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