MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Break (1069); Human-Device Interface Problem (2949); Impedance Problem (2950)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Event Description
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The manufacturer rep reported that the patient (pt) had back fusion surgery in (b)(6) 2021 and one of the leads was cut during the surgery.Rep said today they were going to replace the lead and they discovered that both leads had been removed and no plugs were used in the implant.
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Manufacturer Narrative
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Concomitant medical products: product id 977a260, lot# serial# (b)(4), implanted: (b)(6) 2018, product type lead.Product id 977a260, lot# serial# (b)(4), implanted: (b)(6) 2018, product type lead.Other relevant device(s) are: product id: (b)(4), serial/lot #: (b)(4), ubd: 04-dec-2021, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 10-may-2021, 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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Additional information was received.It was reported the manufacturer representative interrogated the battery prior to surgery without knowing the leads were not in the patient.When connected to the ins, the lead connection showed a great connection, in addition to impedances.After calling and talking to tech services, it was discussed it would probably be best to replace ins since it showed there may be fluid in the battery as there weren¿t plugs used and patient did not currently have perc leads implanted either.It was understood the patient¿s perc leads were accidentally cut with a back surgery.The doctor attempted to replace perc leads and was unsuccessful.Battery was left in hopes to still use, not knowing plugs needed to be implanted in the ins.Patient was referred to a doctor for lead revision and paddle lead was placed with new ins.The issue was resolved and the patient was doing well.The lead s and ins were discarded.
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Manufacturer Narrative
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Continuation of d10: product id 977a260, serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2021, product type lead product id 977a260, serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2021, 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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