Model Number 37714 |
Device Problems
Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)
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Patient Problems
Muscular Rigidity (1968); Pain (1994); Numbness (2415); Ambulation Difficulties (2544); Electric Shock (2554)
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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 the consumer regarding a patient who was implanted with a neurostimulator for spinal cord stimulation.It was reported that the ins was placed on the left side of her body and the ins moved and was going into her spine.Patient was tempted to go to the hospital to get a shot of something to help with the pain but she was avoiding going because of the covid-19.Patient stated it was difficult for her to stand or walk.Patient stated this had been going on for a long time and she had been in pain for many months.Patient also reported seeing eri on her controller.No further complications were reported/anticipated.
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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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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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Additional information received from the patient indicated that they got a bad electric shock when they put on the recharger.They noted that before this issue, they would get small zaps every now and then for the past couple of months.They mentioned that now they got all 8 coupling bars, which began after the bad electric shock.They stated that they get shocked when turning on stimulation.The patient added that they try moving the antenna ¿like 200 times.¿ they also stated that they think the ins moved from their side to their left hip, and almost to their spine.The patient noted that they don¿t feel it has moved any further for months.They mentioned that they recharger has not been connecting with the ins.They stated that they are having pain all through their back and left hip.They stated that they can't even walk across the parking lot without bending over and crying.The patient added that they feel like they are locked up, stiff, and can¿t move.They mentioned that they can¿t sit long and get numbness throughout their hand, arms, and legs.The patient indicated that this started 2-3 months ago.No further complications were reported or anticipated.
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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 received from patient.It was reported that she had an issue with recharging the ins on and off for awhile.Patient stated she would have full coupling then it would go to zero.Patient reported ins had moved.Patient stated she had excruciating pain on the left side near the ins.Patient stated her stim was on its last leg and needed to be replaced.Patient stated she has seen eri from sometime.
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Search Alerts/Recalls
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