MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Break (1069); Connection Problem (2900); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant products: product id: 977a290, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.Product id: 977a290 , serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977a290, serial/lot #: (b)(4), ubd: 29-jan-2025, udi#: (b)(4); product id: 977a290, serial/lot #: (b)(4), ubd: 29-jan-2025, 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 multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the leads were permanently implanted and anchored in the cervical spine.Tunneling was difficult for the physician, and after the leads were passed into the pocket, it appeared that one of the lead's end points was damaged.There were no external factors noted to be contributed.The damaged occurred while the leads were passed from the upper thoracic incision to the implantable neurostimulator pocket.Initially the lead was not fitting into the implantable neurostimulator port (it was not advancing).There was visible damage to the end point of the lead including the last contact.The surgeon decided to trim the lead with the contact point to allow for the leads to advance into the implantable neurostimulator port and to connect with the device.After the lead went in, the impedance reading was initially out of range, but after several repositionings, the lead was manipulated to achieve normal impedance measurements for the top six electrodes and screwed in.Only the bottom 2 were out of range, which was expected as the lead was trimmed.The second lead was fine.The patient had normal stimulation in their upper extremities post-op.There were no patient symptoms reported related to this event.
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Manufacturer Narrative
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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 from the rep indicated that the tunneling tool was discarded.
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Search Alerts/Recalls
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