MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; Stimulator, electrical, implanted, for parkinsonian tremor
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Model Number 37601 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Muscular Rigidity (1968); Discomfort (2330); Insufficient Information (4580)
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Event Date 01/25/2018 |
Event Type
Injury
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Event Description
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It was reported that there was tethered extension wires.On (b)(6) 2018, the patient complained of tightness in his neck due to the extension wire.The physician advised to monitor for now, however, if it becomes too painful, then they could discuss further surgery.On (b)(6) 2023, the patient reported discomfort and stated that his extension wires started to become more prominent immediately after his surgery.During a consult visit for normal implantable neurostimulator (ins) battery depletion replacement, examination showed the extensions were quite exposed but nothing through the skin.On (b)(6) 2023, they explanted the extension and dissected out scar tissue to expose adequate lead length to be able to connect the new extension wires.The issue was resolved.
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Manufacturer Narrative
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D10.Section d information references the main component of the system.Other relevant device(s) are: product id: 37085-60, serial/lot #: (b)(6), ubd: 10-aug-2015, udi#: (b)(4) ; product id: 37085-60, serial/lot #: (b)(6), ubd: 10-aug-2015, udi#: (b)(4).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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