MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
|
Back to Search Results |
|
Model Number B35200 |
Device Problems
Break (1069); High impedance (1291)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
Injury
|
Event Description
|
It was reported that the patient is scheduled for normal implantable neurostimulator (ins) replacement.Caller reports both sides of impedance on the unipolar pairs are showing >5k ohms, but the bipolar pairs are within normal limits.C+1-2- 2.8ma.All unipolar pairs are >5k ohms.Additional information was received from the manufacturer representative (rep) that only the right battery showed investigate impedance >5k on monopolar.The left ins was at eos so unable to check impedance.It is unknown when the high impedances were first observed.The patient's batteries weren¿t replaced on the reported date.The case was cancelled until surgery can be scheduled somewhere.The location and date are unknown at this time.The extension and lead will be checked at the same time.The cause of the impedance issue is unknown.
|
|
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.
|
|
Event Description
|
Additional information received from the manufacturer¿s representative (rep) reported the patient had a complete right lead, extension, and battery replaced on (b)(6) with a right lead fracture identified on x-rays.The patient was going to follow-up with their physician for programming.
|
|
Manufacturer Narrative
|
Section d information references the main component of the system.Other relevant device(s) are: product id 37603 serial# (b)(6) implanted: (b)(6) 2017 product type implantable neurostimulator product id 3387s-40 lot# va1j7tn product type lead.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.
|
|
Search Alerts/Recalls
|
|
|