Model Number NEU_INS_STIMULATOR |
Device Problems
Connection Problem (2900); Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2010, product type: lead.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a manufacturer¿s representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).The rep reported that when the new battery was connected to the old lead, it wouldn't sit well into the battery.The lead was repeatedly connected and reconnected but couldn't get all contacts to work.The rep reported that the patient would be seen post-operatively and options would be discussed.
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Event Description
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Additional information received from the manufacturer representative reported that the exact issue was unknown and the cause of the lead not sitting in the battery was not determined.There were repeated attempts to seat the lead in the battery but the issue was not resolved the day of the surgery and it was unknown what the next steps were.
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Manufacturer Narrative
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Continuation of d11: product id 39565-65 lot# serial# (b)(6) implanted: (b)(6) 2010.Product type lead.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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Search Alerts/Recalls
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