MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Break (1069); Failure to Interrogate (1332); Difficult to Remove (1528); Battery Problem (2885); Communication or Transmission Problem (2896); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id: 37712; lot#serial#: (b)(6); implanted: on (b)(6) 2012; explanted: on (b)(6) 2022; product type: implantable neurostimulator; product id: 39565-65; lot#serial#: (b)(6); implanted: on (b)(6) 2012; explanted: on (b)(6) 2023; product type: lead.Section d information references the main component of the system.Other relevant device(s) are: product id: 39565-65, serial/lot#: (b)(6), ubd: 30-sep-2015, udi#: (b)(4).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.
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Event Description
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On 2022-11-01, it was reported that top lead (0-7 ) would not come out of old ins.Finally came out of the port.Damage caused or discovered during surgery once new battery was opened.Neither lead would go in new battery.Visual damage on leadtips in between electrodes.On 2022-11-02, additional information was received from the manufacturer representative (rep) reporting that the cause of the ins being replaced was due to normal eos as the ins was over 10 years old.On 2023-jan-09, the rep reported the lead is still implanted in the patient but is not being used.Leads were not replaced.On (b)(6) 2023, additional information was received from the manufacturer representative (rep) reporting the patient was scheduled for lead revision tomorrow.Caller stated that patient had a revision on (b)(6) 2022 in which a new ins was placed but they couldn't get the leads in so the ins is implanted but not connected to anything and therefore, hasn't been charged since then.Caller was unsure if patient has any leads implanted currently or not as they haven't met the patient.Caller stated that patient charged controller and was attempting to charge ins in preparation for case tomorrow but controller was showing "no device found".Tss reviewed how to initiate passive recharge cycle(s) at home so that ins will have charge in it tomorrow.Technical services (tss) redirected patient to (b)(6) patient services for any assistance charging.See related reg report#: 3004209178-2022-14392.
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Event Description
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Additional information was received from the rep.The rep reported the cause of the no device found message was the device had not been charged in some time.After completing multiple passive recharge attempts, they were able to connect to the battery.The patient was educated on how to charge the battery before the procedure and was able to charge the device the day before the procedure.Patient was sent home with instructions to keep it charged while waiting for programming at post-op appointment.The patient underwent lead revision surgery.The surgeon explanted both of the unused leads, and implant the patient with a single new lead.Rep reported one lead was returned, and the other lead was discarded by the customer.
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Manufacturer Narrative
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See regulatory report # 3004209178-2022-14392 for information on lead explants.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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