MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97714 |
Device Problems
Migration or Expulsion of Device (1395); Positioning Problem (3009)
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Patient Problems
Seroma (2069); Swelling/ Edema (4577); Insufficient Information (4580)
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Event Date 03/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead.Product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 16-dec-2020, udi#: (b)(4).Product id: 39565-65, serial/lot #: (b)(4), ubd: 08-dec-2018, udi#: (b)(4).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 patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient coughed really hard about 3 days after her revision in 2017 and she felt the anchors "pop".The patient stated their healthcare provider said there was a fluid bubble and swelling that they said they think would just go down.They had to turn their stimulation turned up really high until it was "maxed out".They would only feel stimulation when they were laying down.They did an x-ray and discovered the lead had pulled out, which patient assumed from the beginning. .
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Manufacturer Narrative
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Concomitant medical products: product id 977a260, lot#/serial# (b)(6), implanted: (b)(6)2017, product type lead product id 39565-65, lot#/serial# (b)(6), implanted: (b)(6) 2015,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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