Section d information references the main component of the system.Other relevant device(s) are: product id: 338740, serial/lot #: (b)(6) ubd: 08-oct-2012, udi#: (b)(4); product id: 37085-60, serial/lot #: (b)(6), ubd: 15-jun-2013, udi#: (b)(4) ; product id: 924256, serial/lot #: unknown, ubd: 15-jun-2013.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.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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It was reported that the lead wire was removed with burr hole left behind. agent didn't know if there is a system issue.Additional information was received from the manufacturer representative (rep) the patient had their dbs system removed as it was damaged following a fall from a significant height.The burr hole cover was left behind as they will have the dbs implants replaced at a later date.The device was removed and discarded as there was no product complaint.The fall occurred many years ago, this was before i commenced at medtronic.The patient has not had his dbs switched on for some time.When he had the system removed, the lead and extension were visibly damaged and the surgeon was unable to test them for viability.No actions/interventions were taken to resolve the dbs system damage due to the fall as it could not be repaired due to the traumatic injury.The patient had not been using his dbs when the fall was reported.
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