MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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Model Number 37612 |
Device Problems
Migration or Expulsion of Device (1395); Insufficient Information (3190)
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Patient Problem
Pocket Erosion (2013)
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Event Type
malfunction
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Event Description
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It was reported that the caller inquired if the patient can have an mri if part of the system is no longer fully implanted/intact.The caller stated she didn't know if there was an actual issue with the dbs but stated the patient notified a nurse that "it is coming out".The caller was unable to clarify what "it" refers to.The caller also noted that when the patient was asked where something is coming out of his body he said "all over".The caller noted the patient has not been seen by an hcp for his dbs in like 6 years.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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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), which was confirmed with the healthcare provider (hcp), reported the patient didn't show up for their mri so there was no further information available.The hcp noted surgery may be considered and the date would be november 10th, but it was unknown if there was any issue with the device as no further testing was done.
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Search Alerts/Recalls
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