MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37603 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Pain (1994); Weakness (2145); Discomfort (2330); Neck Pain (2433); Ambulation Difficulties (2544)
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Event Date 11/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 37603, serial#: (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.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 on regular occasions the patient has "alarming episodes" she believed to be related to the deep brain stimulation (dbs) device.She has pain that starts at ear level and shoots up her head to the top of the forehead and around the right side.The episodes make the patient very weak and she cannot stand straight.The patients arm gets very sore and tired, too, and the following day she has difficulty eating.The last episode lasted three days, but they usually last one day.The pain was described as a shooting, stabbing pain, and is always in the neck on the right side.The patient described her pain as a 12 on a scale of 1 to 10.She has been hospitalized multiple time as a result of these episodes.The surgeon who implanted the device was consulted, but was allegedly unable to provide insight.The patient was implanted for essential tremor and movement disorders.
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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.The initial "episode" occurred on (b)(6) 2019, and the patient went to the emergency department.The pain was intermittent, but stimulation was always on and delivering good therapy.A ct scan was performed, but results were not known.The patient was prescribed medication for the pain which helps, but makes her sleepy.An appointment was scheduled for (b)(6) 2020 to investigate the issue, and an impedance check was planned.
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Event Description
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Additional information was received from the manufacturer representative (rep) stating that the results of the impendance check were all good.A ct was performed.It was also indicated that the neurologist thinks it is cervical dystonia.Patient was scheduled for botox injections.
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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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