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Model Number 97715 |
Device Problems
Failure to Interrogate (1332); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896)
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Patient Problems
Pain (1994); Paralysis (1997); Ambulation Difficulties (2544); Electric Shock (2554)
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Event Date 03/11/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 97745, serial# (b)(4), product type programmer, patient.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 the patient kept receiving no device found on their controller.On (b)(6) 2021 the patient was sitting and on their right leg, on the inside, it felt like they were being electrocuted.The patient could not move, walk, and it was like they were paralyzed and couldn't turn their ins off because the controller kept stating no device found.The patient's friend grabbed their controller and kept trying to turn their ins off, however it took 5-6 tries for the controller to connect with the ins.The patient was going nuts and noted it was like electricity was going through their leg and they could not move their leg.The patient was screaming in pain, they did not know what to do and they felt like they were dying.They were able to turn the ins off and it took a good five minutes to calm down.The patient confirmed they were not covering the top of their controller with their hand, the controller was close to the ins, the controller and ins were both charged when the issue occurred.There was no damage to the pins in the battery compartment and the antenna jack.The patient unlocked their controller and noted that their stimulation was off.The patient was afraid to turn their ins on.The issue was not resolved.A new controller was requested.Considerations for adjusting therapy was reviewed and the patient was redirected to follow up with their healthcare provider.
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Manufacturer Narrative
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Continuation of d10: product id 97745, serial# (b)(6), product type programmer, patient.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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Search Alerts/Recalls
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