MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Intermittent Continuity (1121); Device Difficult to Program or Calibrate (1496); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Inadequate Pain Relief (2388); Sleep Dysfunction (2517)
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Event Type
malfunction
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Manufacturer Narrative
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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 for the past several weeks the patient has been waking at 2am and finding that their back spine stimulator appears to not be working.At around 5am it kicks back on.This is aggravating their pain between 2am-5am is quite intense and causes them to lose sleep.
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Event Description
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Patient reported that it still appears as their device is not working properly at all times (especially in the mornings) and they can no longer elevate or reduce the stimulation on the controller.
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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.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 was received from the patient (pt) and it was reported that around 2 am every night, he gets woken up due to pain.Pt explained that the ins doesn't shut off, but the stimulation is "so weak, he can barely feel it" (the stimulation).Pt added that the pain that the stimulation masks "hits him" and he has to wake up.Pt confirmed that the ins battery is charged, and when he wakes up from the pain, he changes position.Pt states around 5a he is able to get back to the point where he has adequate therapy and is no longer in pain.Pt confirmed that he has 4 programs available on his device, and none of the programs had adaptive stimulation enabled.Pt states that when he was initially implanted, he set the stimulation to 1.3ma, but now he keeps the stimulation at 3.0ma and doesn't change it.Pt confirmed when he wakes up at 2a from the pain, the stimulation is still at 3.0ma and the ins is on, but that he doesn't feel stim.Reviewed considerations with positional changes and the therapy, raising the stimulation if appropriate, and recommended monitoring the issue.The issue was not resolved through troubleshooting.Pt will monitor issue.Pt mentioned during the call that he hasn't seen his managing healthcare provider (hcp) since the post-implant check.
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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 was rec'd from the patient.It was reported that patient already had a patient rep try to trouble shoot their device and it did not work.Ins isn't working properly because the therapy is not functioning to cover his pain.This issue is especially noticeable when he is laying down, causing him to wake up.Pt states that he contacted a rep 3 weeks ago about facilitating a reprogramming appt.But hasn't heard back from this rep.
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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.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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