MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problems
Unintended Collision (1429); Delayed Charge Time (2586); 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 05/04/2022 |
Event Type
malfunction
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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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It was reported that the patient (pt) fell (b)(6) 2022 and hit around the ins area.The pt states since (b)(6) 2022 it takes longer to charge the implantable neurostimulator (ins) and they are not getting coupling boxes when recharging (use to be about 15-20 minutes and after the fall, it is taking an hour and sometimes does not get fully charged.) the pt states the recharger antenna is not damaged.
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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 was received from the consumer who reported that they fell (b)(6) and fractured the humorous bone in their right arm near their shoulder.The circumstances that led to it taking longer to charge the ins was that it was swollen and tender and they couldn't recharge it long.It was reported that it works fine now that the swelling went down.No steps were taken except to wait for the swelling to go down and the issue was resolved at this time.
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Search Alerts/Recalls
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