MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97714 |
Device Problems
Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Human-Device Interface Problem (2949)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/19/2019 |
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 consumer regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient started having problems with charging the ins around (b)(6) 2019.The ins would not stay charged; it would only stay charged for one week and they have had to keep charging it more often.Then, around the beginning of (b)(6) 2020, the ins started taking longer to charge.On (b)(6) 2020, the patient spent 8 hours charging the ins and it only got to 50% charge.The patient confirmed that they were able to maintain 4-6 boxes when charging, and hadn't gotten 8 boxes on (b)(6) 2020 when they were charging.Reasons for these reported ins recharging issues were reviewed and the patient was redirected to see their doctor.The patient has an appointment scheduled for (b)(6) 2020 to meet with their physician.No symptoms were reported.No further complications were reported or anticipated.
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Event Description
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Additional information was received.It was reported the circumstances that may have led to the ins having charging issues was when the healthcare provider put the stimulator in, they reported they hit scar tissue and was not able to put the stimulator where they wanted.The healthcare professional did not know why the patient was experiencing charging issues.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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