MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number B35200 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problems
Muscular Rigidity (1968); Ambulation Difficulties (2544); Insufficient Information (4580)
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Event Date 12/09/2023 |
Event Type
Injury
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Event Description
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Information was received from a patient regarding the patients therapy.The reason for call was patient reported they are having return of symptoms and they are stiff as a board and can hardly move.The patient stated they think their therapy is turned off due to return of symptom's even though the handset says therapy is on.Patient said they are totally stiff and it has been getting worse and worse.The caller was requesting that a mdt rep go to the hospital university of minnesota medical center to reset the implantable neurostimulator (ins).Patient service specialist reviewed reps role and provided nas to a charge nurse at the hospital to page the local rep.
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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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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 reason for call was that the caller reports that the therapy is turned off, but the handset shows that the therapy is turned on.The caller reports that it is off because their legs feel like they are 20 pounds a piece and they having "all kinds of trouble".The caller reports that their head, arms and legs are heavy and feels like a ton of bricks.The caller reported that they were seeing that the therapy is on, but they did not have the handset at the time of the call.The caller reported that they would go get the handset and call back, the caller did not want ps to hold while they obtained it.They have not had any falls or trauma.The caller had already contacted the hcp who directed them to contact medtronic.
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