Model Number 37800 |
Device Problems
Break (1069); Migration or Expulsion of Device (1395)
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Patient Problems
Scar Tissue (2060); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 435135 lot# nht008746n serial# implanted: (b)(6) 2008 explanted: (b)(6) 2020 product type lead product id 435135 lot# nht007940n serial# implanted: (b)(6) 2008 explanted: (b)(6) 2020 product type lead.Other relevant device(s) are: product id: 435135, serial/lot #: nht007940n, ubd: 20-dec-2009, udi#: ; product id: 435135, serial/lot #: nht007940n, ubd: 08-feb-2010, udi#: 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 gastric stimulation.It was reported that the patient's gastric ins was removed because it died and the wires got broken.
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Event Description
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Additional information was received from the patient.They reported that their lead wires are not connected properly due to 'be in' broken.They first noticed this in 07/2020.It was unknown if the cause was determined, but the most likely cause or contributing factor was "falling." they stated that they must have the lead wires replaced, but the doctors were refusing to do so.The device was still implanted and device removal or replacement was not planned.
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Manufacturer Narrative
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B3: date is estimated; month and year are valid.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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Manufacturer Narrative
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Continuation of d10: product id: 435135, lot#: nht008746n, implanted: 2008 (b)(6), explanted: 2020 (b)(6), product type: lead.Lot#: nht007940n, implanted: 2008 (b)(6), explanted: 2020 (b)(6), 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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Event Description
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Additional information was received from a healthcare professional (hcp).The hcp reported that when asked to clarify if the wires becoming broken were another reason for explant or if the issue occurred during explant due to depleted battery the hcp said it was likely during explant.Operation started with extensive lysis of adhesions and mobilization of the gastric pacer wires.The issue was first noticed on 2020 (b)(6).
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Search Alerts/Recalls
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