Model Number 37612 |
Device Problems
Unstable (1667); 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 11/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B3: date is approximate.Year is confirmed valid.Continuation of d10: product id wr9200, serial: (b)(6), product type: 0213-recharger; implant date n/a; explant date n/a.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 a recharger.The patient reported difficulty charging the implantable neurostimulator (ins), probably for the last month, they charge every night but have not been able to charge higher than 75% for at least a month.The patient (pt) checked their ins battery level using the communicator and the dbs app and confirmed their ins battery showed 50%.The following troubleshooting steps were performed: confirmed communicator is off while using the charger, recommended patient use a thin t shirt, reset the charger by holding down the power button twice off the dock and twice while on the dock, restarted the handset, repositioning the charger numerous times, recommended moving away from possible sources of emi (pt moved their alexa to another room), pt was successful to connect very briefly then lost connection numerous times, they said the light went solid green and stopped beeping but never started clicking then the beeping started happening again.The issue was not resolved through troubleshooting.An email was sent to the repair department.No symptoms 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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Event Description
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Additional information received from the consumer reported the circumstances that led to the charging issues was the inability to ch arge the stimulator.To try and resolve the issue they got a new charger, but it only charged part of the time.The consumer believed the issue was their stimulator turning over in their chest, and when this happened it didn¿t charge.
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Search Alerts/Recalls
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