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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN COMMAND; CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND ATTAIN COMMAND; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 6250V-EH
Event Date 04/16/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during implant, the patient's coronary sinus was dissected during coronary sinus access.The catheter was removed and the left ventricular (lv) lead placement was abandoned.The physician chose to place the lv lead into the lv port and coil the lead in the pocket.The patient would return at a later date to place that lv lead.No further patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN COMMAND
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI 
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI  
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11797557
MDR Text Key249718597
Report Number9612164-2021-01837
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00763000160289
UDI-Public00763000160289
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 05/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/06/2022
Device Model Number6250V-EH
Device Catalogue Number6250V-EH
Device Lot Number0010555117
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/16/2021
Initial Date FDA Received05/10/2021
Date Device Manufactured02/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age88 YR
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