Model Number 37612 |
Device Problems
Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2023 |
Event Type
malfunction
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Event Description
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It was reported that the clinician was having difficulty communicating with the implant using the tablet, handset, and wireless recharger today.Caller stated patient hasn't charged implant in over a week.Agent reviewed how to do physician recharge mode using the wireless recharger today to charge it up.Technical services reviewed to spend as much time charging the implant to allow for enough time to work with the implant and programming.X-rays were taken to check the implant position in the patient's body.Per the manufacturer's representative, it appears that the implant is in the correct orientation.No symptoms were reported.
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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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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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Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the overdischarge was resolved as the device was able to be charged to 25%, and was then able to be interrogated.The rep mentioned the patient had grown so their mom and physician thought the implant had changed position to be deeper and was less visible over time.Lately the patient had to push on the puck of the wireless recharger to it to charge/stop beeping.In addition, the patient had been charging lying down, but they were instructed it was better to charge sitting up.
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Search Alerts/Recalls
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