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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC EUROPE SARL COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTPA2QQ
Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 03/27/2024
Event Type  Injury  
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
It was reported that the patient received inappropriate anti-tachycardia pacing and inappropriate shock for atrial fibrillation (af) with rapid ventricular response that the device classified as ventricular fibrillation (vf).The cardiac resynchronization therapy defibrillator (crt-d) remains in use.It was also noted that the right ventricular (rv) lead exhibited intermittent undersensing during ventricular arrhythmias and the left ventricular (lv) lead capture could not be confirmed.The leads remain in use.No further patient complications have been reported as a result of this event.
 
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
It was further reported that the patient experienced vf and was shocked appropriately.Per healthcare professional, patient received device shock for vf.The patient went to the emergency room, was hospitalized, chest x-ray performed, and had low magnesium plus potassium levels/hypokalemia.Once labs were corrected no more arrhythmias.No changes made.Electrograms (egm) shows dual tachycardia, atrial fibrillation (af) and ventricular fibrillation (vf).The patient was started on, administered antiarrhythmic medication.Additionally, it was stated that the patient hit head during shock.
 
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Brand Name
COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ  1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ   1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key19150780
MDR Text Key340675656
Report Number9614453-2024-01565
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00763000178093
UDI-Public00763000178093
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/14/2023
Device Model NumberDTPA2QQ
Device Catalogue NumberDTPA2QQ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/27/2024
Date Device Manufactured01/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
407658, LEAD, 479888, LEAD, 6935M62, LEAD.
Patient Outcome(s) Life Threatening; Hospitalization;
Patient Age75 YR
Patient SexFemale
Patient Weight72 KG
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