MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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Model Number 37612 |
Device Problems
Failure to Power Up (1476); Charging Problem (2892)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2024 |
Event Type
malfunction
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Event Description
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It was reported that the patient's wireless recharger (wr) will not charge.The patient stated that no lights are coming on the recharger and it will not turn on.Patient confirmed there is a green light on the docking station and confirmed that there is a secure connection.Patient service specialist had them try a reset of the wr on and off the docking station, but no lights came up on the recharger.The patient tried a different outlet but the issue was not resolved.The issue was not resolved through troubleshooting.An email was sent to the repair department.No symptoms were reported.
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Manufacturer Narrative
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Section d references the main component of the system.Other medical products in use during the event include: brand name ; product id wr9200 (b)(6); product type: 0213-recharger.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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Manufacturer Narrative
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Section d10 references: product id (b)(4) serial# (b)(6) product type recharger product id (b)(4) serial# (b)(6).Product type recharger 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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Event Description
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Additional information received from the consumer reported they received the replacement recharger and everything worked fine, but yesterday they were trying to get into the recharger app and the handset couldn¿t find the recharger and they saw a 1713 or 1513 code.During the call the consumer was able to charge the implant with the new wireless recharger, but when they tried to connect with the recharger app they got the ¿not found recharger¿ screen.It was reviewed the new recharger would need to be paired with the handset but showed the ¿not found recharger¿ screen.The handset was powered down and the recharger had a hard reset performed which allowed them to resolve the issue.
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