MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37601 |
Device Problems
Failure to Interrogate (1332); Energy Output Problem (1431); Communication or Transmission Problem (2896)
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Patient Problems
Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)
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Event Date 10/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 37642, lot# serial#: (b)(4).Product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.
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Event Description
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2it was reported that 4 or 5 days ago, the patient noticed that he would receive the poor communication screen when trying to communicate with his programmer.Patient (pt) said he has not had any falls or trauma.Pt mentioned he tried using new batteries, and also tried to communicate with and without an antenna.Pt mentioned that he has had a return of shaking and he believes the implant is turned off and he is shaking so bad.Pt stated he believes he may be able to feel some stimulation or something.Patient services offered to email repair for a replacement programmer and if the pt still cannot communicate with the new programmer, to follow up with his managing provider to check the device.
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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 cause of the poor communication and return of symptoms was nothing as nothing different happened.The programmed just stopped communicating as over 4-5 days it only worked once; ¿probably 1 in 50 times.¿ the replacement device resolved the poor communication and return of symptoms.It was noted it was confirmed the implant was off as the essential tremor symptoms occurred, but the consumer ¿still had something happening in their head.¿.
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Search Alerts/Recalls
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