MEDTRONIC NEUROMODULATION INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number NEU_INTERSTIM_INS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Scar Tissue (2060); Sepsis (2067); Coma (2417); Insufficient Information (4580)
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Event Type
Injury
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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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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient (pt) is suing their previous doctor because they were a "horrible physician" and implanted the ins 9 times and reported pt got sick and ended up in a coma, with sepsis and an infection, it was horrible." pt stated their new and current doctor had to take out the device because their previous doctor "left the wires in but he took out the device".Asked for event date and pt stated they are "going on like 12 years of a lawsuit". pt stated their current doctor gave it another try, fixed their problems, did it right the first time, and saved pt's life.Their current doctor took out what their previous doctor left in (the wires) and removed the implant, had pt wait a year, then implanted a new interstim system (pt's current ins).Pt stated the new implant has worked perfectly.Pt stated one time a manufacturing representative met with the pt at an appointment to make sure everything was working due to all the issues pt had with their previous doctor.Pt stated the manufacturer had never been an issue, the issue has only been with pt's previous doctor.Pt stated prior to getting current implant ,pt had a different implant and they confirmed that both devices are the same manufacturer.They confirmed that their previous implant is the implant that was related to all issues reported in this case.The implant was implanted prior to 2013.Pt stated they think their current doctor took that implant out in 2012 so pt thinks between 2007-2012 pt had "9 replacements of an interstim".Pt stated they almost died.Pt later stated "in the course of 1 year i had 6 implants".When asked if the same device was re-implanted or if they got a new device each time, they stated "i ended up with infections, it had to be taken out, then i had to have a new one put in, i have scars all over my back where the interstim is".
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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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Manufacturer Narrative
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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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