This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Information was received from a manufacturer¿s representative (rep) who reported the recharger gave a slow pulse as it searched for the implant, but then it would beep like it connected, but disconnected shortly after so they couldn¿t recharge.It was noted the consumer was implanted three days ago so it could be related to swelling so they were going to wait for the swelling to go down before trying again.Additional information received from the manufacturer¿s representative (rep) reported the charging issues were most likely associated with depth.The rep met with the patient today and indicated they were charging in search mode and wanted to compare charge duration of a normal charge with a poor coupling charge.Additional information was received from the manufacturer's representative (rep).The suspected cause of the issue was swelling as patient reports that the swelling has subsided and the patient is able to charge his device with poor coupling. action/interventions included waiting for the patient's swelling to subside.Additional information was received from the rep reporting the rep was able to confirm that x-rays were taken and show that ins is not flipped.The patient is younger with more muscle tone and some adipose tissue.The patient is still having connection issues with wr and ins where the wr finds the ins and it connects for 30 seconds and then starts beeping.Patient is 4 weeks post-op.The rep's suspicion is recharging issue is related to depth.Rep will work with the patient and surgeon on next steps and additional troubleshooting.Patient services also discussed topics such as depth of ins, flipped ins, optimal starting position of wr over ins, discussed using insr to troubleshoot coupling and al feature.Additional information was received from the rep that patient has been able to find a position where he can better charge.The physician feels that it was a combination of swelling and the implant too deep.They are considering revising the depth but have not committed to doing so as yet.
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