MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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Model Number 37612 |
Device Problems
Failure to Deliver Energy (1211); Pocket Stimulation (1463); Battery Problem (2885)
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Patient Problems
Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: product id: 37642, serial# (b)(6), product type: programmer, patient.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 patient regarding an external device.The patient reported that every time they try to connect to their implanted neurostimulator with their patient programmer, they see a doctor on the screen.The patient did not remember further detail about the screen they saw. the patient removed the batteries from the programmer and reinserted them, but the issue was not resolved.During the call, the programmer was showing a warning screen that indicated the implanted neurostimulator (ins) battery was in a discharged stated and therapy has stopped.The patient mentioned that they last charged their ins on friday.The patient said they will charge their ins will call back if they require further assistance.No symptoms reported.
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Event Description
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Additional information received from the consumer reported they didn¿t know what the circumstances were they lad to the discharged implant and programmer issues.To resolve the issue the consumer recharged it and worked when completely dead, but when they charged it if they tried to change settings they got the ¿doctor,¿ but if they kept doing it, it would work.The consumer also mentioned getting tingling around the battery unit in their chest.
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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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