MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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Model Number 37612 |
Device Problems
Overheating of Device (1437); Failure to Power Up (1476); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Shaking/Tremors (2515); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Section d information references the main component of the system.Other relevant device(s) are: product id 97754 serial# (b)(6) product type recharger product id 37761 lot# serial# (b)(6) product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 97754, serial/lot #: (b)(6) udi#: (b)(4) 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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It was reported that a couple of weeks ago they noticed the desktop charger (dtc) cord was damaged, so they put super glue on it.The caller said the dtc was still charging the recharger at that time, but they noticed that the recharger got really hot when the dtc was connected to it.Last night, the caller noticed that the recharger would no longer power on.As a result, the patient was unable to charge their implant and they experienced a return of symptoms.The caller said the patient's tremor "went bananas," and they were unable to hold a glass or do anything.The caller also mentioned that the patient fell and hurt their back the night before last, but they did not know if the fall was related to the device/therapy.A replacement dtc was sent.
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Search Alerts/Recalls
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