MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problems
Failure to Power Up (1476); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Event Description
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Patient reported that their patient programmer wasn't working anymore.They said the issue had been going on for about a month.The programmer would connect with the implant but then it wouldn't power on sometimes because it was old.Patient said when they were getting a heart echo the programmer wouldn't work.An email was sent to the repair department to replace the patient programmer.Patient asked about getting a handset/communicator.Patient services (pss) reviewed info and redirected patient to healthcare provider.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 activa; product id 37642 (serial: (b)(6)); product type: 0201-programmer patient.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.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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Manufacturer Narrative
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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 healthcare provider (hcp) reported the programmer was outdated and not working.
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Search Alerts/Recalls
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