Model Number 97715 |
Device Problems
Device Difficult to Program or Calibrate (1496); Data Problem (3196)
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Patient Problems
Pain (1994); No Known Impact Or Consequence To Patient (2692)
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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 manufacturer's representative (rep) regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - spinal pain.It was reported that stimulation kept going to zero.The manufacturer's representative (rep) wanted to know if patient can turn adaptive stimulation (as) on and off.The rep also mentioned that patient was cycling.Technical services (ts) reviewed with the rep that if patient had access to turn cycling on/off, then that overrides patient's ability to turn as on/off.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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Event Description
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Additional information was received from the patient.It was reported via medwatch that the patient had increased pain.No further complications were reported.
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Event Description
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Additional information was received from a manufacturer¿s representative (rep).The rep guessed the patient¿s weight to be 225-250 pounds.The rep reported that the patient¿s adaptive stimulation settings were not set correctly.The rep gave the patient education on adaptive stimulation.The rep reported that the patient decided to just have adaptive stimulation turned off and this corrected the problem.No further complications were reported.
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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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Search Alerts/Recalls
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