Model Number 37612 |
Device Problems
Migration or Expulsion of Device (1395); Delayed Charge Time (2586)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the patient stated having difficulty charging lately.The pt said that the charging time was taking longer than usual.The hcp noted that they could only see the 3 charging sessions today, and all of them were at around 25-50% starting value with a charging time of only 1 hrs.The caller said they took x-rays of the chest, neck, and skull.Per the quick review, the hcp said the ins looked to be in a good position and not flipped, even though the ins seemed to have some movement in the pocket.Ts reviewed the importance of having 6-8 coupling bars for better efficiency, insr antenna placement, and average recharging time/quartile.Given the lower battery status and limited time the pt was spending, discussed the need to charge longer of at least 2-4 hrs.To get the battery up to full.The caller indicated they would have a rep contact the pt.Ts also asked the patient to call patient services for assistance during business hours.No symptoms/complications 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.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 consumer reported to resolve the movement in the pocket they had to charge longer which resolved the charging issue and they were now charged.
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Search Alerts/Recalls
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