MEDTRONIC EUROPE SARL COBALT¿ HF CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
|
Back to Search Results |
|
Model Number DTPB2D1 |
Device Problems
Mechanical Problem (1384); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917); Impedance Problem (2950)
|
Patient Problem
Shock from Patient Lead(s) (3162)
|
Event Date 03/11/2023 |
Event Type
Injury
|
Event Description
|
It was reported that during use of the cardiac resynchronization therapy defibrillator (crt-d) the patient received multiple inappropriate shocks for what appeared to be noise.It was noted that the right ventricular (rv) lead and left ventricular (lv) lead exhibited noise.The device was evaluated and the rv lead and lv lead impedance were high, undefined.A review of the device data revealed a sudden impedance change combined with noisy/non-physiologic sensing for the rv lead, and lv lead.It was noted that the cause was suspected to be a device header issue but could not be confirmed.The crt-d was explanted and replaced.The rv lead, and left ventricular (lv) lead remains in use.No further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Concomitant medical products: product id: 694765.Lead implanted: (b)(6) 2009.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
|
Product event summary: the device was returned and analyzed.The returned device indicated shorting/low resistance in a tantalum cap acitor.Device analysis confirmed the customer complaint of high/undefined atrial and ventricular pace impedance measurements.Hybrid analysis determined that elevated pacing lead impedances and reduced pacing pulse amplitudes were confirmed and traced to a leakage in the tantalum capacitor.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
|
|
|