Continuation of d10: product id 37603 lot# serial# (b)(6), implanted: (b)(6) 2016, explanted: product type implantable neurostimu lator product id 37642 lot# serial# (b)(6), implanted: explanted: product type programmer, patient section d information references the main component of the system.Other relevant device(s) are: product id: 37642, serial/lot #: (b)(6), ubd: , udi#: (b)(4), h3: analysis of the 37642 programmer (serial number (b)(6) revealed corrosion.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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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It was reported that she tried to turn the programmer on but it would not respond.Caller tried 'medcell professional' batteries which she stated were new.The caller also tried regular alkaline batteries. caller stated the batteries were placed in the programmer correctly. the caller stated they were not aware of product being dropped or wet.An email was sent to repair to replace the programmer.(b)(6) 2021, rtg0228912 (hcp): the healthcare provider (hcp) called back and inquired how to use the patient programmer (pp).Technical services (ts) reviewed how to sync.Upon having caller test to see if device turned on, it appears that batteries she used from primary call were depleted.After grabbing a different set, pp turned on and functioned as normal.
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