MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problems
Break (1069); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id: 978b128, lot# unknown, explanted: (b)(6) 2024, product type: lead.Section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: unknown, ubd: unknown, udi#: unknown g2: country united kingdom 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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Event Description
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Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implan ted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that surgeon went to replace battery but the lead twisted and snapped inside battery.They did a full system replacement.Issue resolved.Ins and lead will be returned.2024-feb-16 e1_nni (for, rep): no new information 2024-feb-19 e2, e3, 1 image (for, rep): no new information.
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Manufacturer Narrative
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Analysis of the implantable neurostimulator (ins) showed the device passed functional testing; however a lead or lead parts were observed inside the implantable neurostimulator (ins) connector port.Continuation of d10: product id: 978b128, lot# unknown, explanted: (b)(6) 2024, product type: lead.Analysis identified that the outer insulation of the lead was twisted.Analysis identified that all conductors were broken at the proximal end of the lead as the result of factors beyond intended reliability.Analysis identified a break in the insulation under connector 0 at the proximal end of the lead, consistent with twisting damage.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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