MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97714 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Communication or Transmission Problem (2896); Human-Device Interface Problem (2949)
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Patient Problem
Pain (1994)
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Event Date 03/24/2021 |
Event Type
Injury
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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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Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that an mri tech reports pt has been getting poor communication screen on his programmer for almost a year.Technical services specialist (tss) reviewed device is likely in overdischarge, reviewed relevant mri info for depleted devices and redirected pt to managing hcp to have device checked or complete mri eligibility form.No symptoms were reported.Additional information was received from the patient on may 2nd.It was reported that the mri was not related to the implant.The ins was intentionally overdischarged.Per the patient, the device was initially improperly implanted in their back.The recharging issue is resolved but properly re-implanting the unit is not resolved.They are unsure this will provide the relief that it was intended to provide.The patient doesn't know if there is any discussion as to whether or not the relocation of the device will result in any relief of the worsening back pain.Additional information was received from the patient on june 10th.The improper implantation had nothing to do with the device.It was all on the healthcare provider (hcp).When pt was redirected back to hcp, it was their request to have the device removed as it was not providing any relief.After discussion with the hcp, they suggested that they could properly explant the device since so far the device has not been beneficial or reposition the device.Sometime in the future, the device will be repositioned but unknown when.
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Search Alerts/Recalls
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