MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37612 |
Device Problems
Failure to Deliver Energy (1211); Failure to Interrogate (1332); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient can't handset to the communicator and therefore is unable to see the charge level of their implants.Caller reports after resetting and powering the phone off then on, connection is still unsuccessful. the manufacturer representative (rep) attempted to assist the patient but the caller stated that handset didn't even have the 3 icons (located at bottom of the screen- apps, home button and back button).The rep attempted connection with a clinician tablet and wireless recharger and connection with the implants was unsuccessful.It was determined that one of the implants was turned off so rep turned it back on.A new handset and communicator was sent to the patient. it was indicated that the patient is going to have surgery in a couple of weeks to replace both implanted batteries due to the difficulty the patient is having with maintaining the devices.The rep stated they have done multiple trainings with the patient on charging and using equipment.Additional information received from the manufacturer¿s representative (rep) reported stimulation was turned back on with the clinician tablet.The patient¿s handset wouldn¿t connect to the communicator or the wireless recharger.Troubleshooting was unsuccessful for both so a replacement handset and communicator were ordered.There was no problem with the clinician tablet connecting to the neurostimulator or with the patient using their wireless recharger to charge the implant.The cause of the connection issue wasn¿t determined, but there was no problem with the implant.
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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) reported the patient was able to charge their implant, it was just the handset wouldn't connect to the communicator or the wireless charger to be able to see the charge level.On november 7th the patient had surgery to have the rechargeable devices replaced with primary cell devices.The devices were not going to be returned.
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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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