MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 37712 |
Device Problems
Failure to Deliver Energy (1211); Failure to Interrogate (1332); No Device Output (1435); Charging Problem (2892); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927)
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Patient Problem
Insufficient Information (4580)
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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 failed back surgery syndrome and spinal pain.It was reported that the pt stated that they had surgery on their knee due to knee issues (not related to device/therapy) and turned ins off for the surgery.Pt said they have not been able to get the ins to come back on after the surgery, so ins has probably been off for a week and a half.Patient services specialist (pss) asked, pt has only tried to use implanted neurostimulator recharger (insr) since the surgery.Pss had pt try to connect with patient programmer (pp) and after putting in new batteries, pt reported poor communication screen (pt does not use pp antenna).Pt then tried to use insr and reported reposition antenna screen.Pss asked, pt said they last charged ins probably 2-3 weeks ago and a charge usually lasts 2 weeks.The issue was not resolved through troubleshooting.
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Event Description
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Additional information was received.It was reported the patient's battery was dead and was 9 years old.The battery was replaced on (b)(6) 2021 and the issue was resolved.
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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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