MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Unstable (1667); Malposition of Device (2616); Charging Problem (2892)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/21/2020 |
Event Type
Injury
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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 consumer regarding a patient with an implantable neurostimulator (ins).It was reported the patient's ins would not charge.The caller stated they were seeing no device found.The caller was instructed to start a charging session and ended up cycling through passive recharge mode multiple times and the highest number they could get was 76.It was noted the recharger was stuck in passive recharge mode.The caller stated they were doing that for an hour on (b)(6) 2020 and did not get anywhere.A new recharger was requested.Additional information was reported that the patient was unable to charge her battery due to the excessive angle the battery was implanted at.The cause is unknown, but maybe a suture broke.The battery site was palpated and discovered the angle.The rep explained to the doctor that there are only two main reasons that a patient cannot charge their ins battery if all the equipment is functioning properly, which is fluid or the angle of the battery.In this instance it was a combination of things, but the battery angle was excessive in the main culprit.The doctor is going to revise the battery, but has not scheduled the surgery as of today.No further information was reported.
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Manufacturer Narrative
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Concomitant medical products: product id 97755 serial# (b)(6) product type recharger 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 and it was reported that the date of revision was unknown.There would be a pocket revision as the battery was at a 45° angle.The cause was unknown and the issue had not yet been resolved.No further complications were reported or anticipated.
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