MEDTRONIC PUERTO RICO OPERATIONS CO. SOLARA CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
|
Back to Search Results |
|
Model Number W1TR03 |
Device Problem
Unable to Obtain Readings (1516)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/16/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Concomitant medical products: 429678, lead, implanted: (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that during the device change out, when the leads were hooked up to the new device, the physician was unable to measure all the left ventricular (lv) lead impedance measurements when using the lead impedance test.Only two of the five measurements could be obtained.All lv lead impedance were normal with the old device.Troubleshooting was done with no success.A new device was then tried with the same issues in getting all the lv lead impedance measurements.Each lv lead configuration was subsequently programmed and then tested with normal impedance results.That device was implanted and remains in use.No patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the lead impedance data was missing/invalid.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
|
|
|