MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
|
Back to Search Results |
|
Model Number 37601 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pocket Erosion (2013)
|
Event Date 11/16/2023 |
Event Type
Injury
|
Event Description
|
It was reported that the patient seemed to be having an allergic reaction to the implantable neurostimulator (ins).Technical services reviewed some images and it looked a bit like the body was rejecting the neurostimulator and is 'pushing it out' of the body/pocket.The manufacturer representative (rep) indicated that the hospital ran an allergy test to identify the potential allergy.It seems the patient might be allergic to beryllium and/or potassium dichromate.The physician was thinking in replacing with another ins.They inquired if these materials might be present within some of the alloys listed.It was reviewed that it was unlikely these substances would be present in the raw materials used in the ins but cannot say for certain.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Additional information was received from the manufacturer representative (rep) that surgery was performed on the (b)(6) and a percept rc was implanted.The device was discarded.
|
|
Search Alerts/Recalls
|
|
|