MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B3: date is approximate.Year is confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 978b128 (lot: va2bcnm); product type: 0200-lead; implant date ; explant date.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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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that the patient needed an mri scan today of their shoulder and brain; however, when they placed the patient in mri mode, the mri mode read the patient's eligibility could not be determined.Mri code: 015310.Patient services (ps) reviewed the meaning of the code with the patient and the patient explained the reason for the mri mode programming was: when they were implanted with their current system, the healthcare provider (hcp) did not feel confident removing the patient's original lead during the replacement procedure because "the lead was so low" in the patient's body.The patient stated that they were referred to a neurosurgeon who was able to remove the lead and the patient stated they knew it had been entirely removed because now they had the lead at their home.The patient also stated they'd just done an x-ray on their abdomen that showed the product was no longer there.The patient stated they knew no further information about the placement of their initial lead being 'so low' when ps inquired.Ps redirected the patient to their hcp to have the mri mode updated to show they no longer had the abandoned product.The caller stated they had an appointment scheduled with their hcp on friday, 2023-oct-20.Ps reviewed with the patient let the hcp know in advance they needed the programming in the event they needed to page a representative to be at the appointment.The patient stated they would let their hcp know.Documented reported event.No further action was taken by ps.
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Manufacturer Narrative
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Continuation of d10: product id: 978b128, lot# va2bcnm, 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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It was noted that the ins and lead had been implanted past the use-by date (ubd).
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Search Alerts/Recalls
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