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

Model Number	6250V-45S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that one hour post implant and atrioventricular node ablation resulting in an underlying junctional rhythm, the patient experienced runs of ventricular tachycardia (vt) and a sustained torsade's episode.The right ventricular (rv) lead exhibited rising thresholds.The next morning the rv lead displayed undersensing, with high and unstable thresholds and a micro-dislodgement.An rv lead revision was planned.It was further reported that the left ventricular (lv) lead was no longer functioning and had dislodged into the rv.The rv was revised to a new location, remains in use, and had measurements all within normal ranges.The lv lead was removed and when the physician attempted to regain access to the coronary sinus, the delivery catheter perforated and "made its own track." an echocardiogram was performed an noted a small pericardial effusion.The lv lead replacement was abandoned and the device was downgraded.The patient was administered albumin and no further intervention was needed.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN COMMAND
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9593726
• Report Number: 9612164-2020-00252
• Device Sequence Number: 14223069
• Product Code: DQY
• UDI-Device Identifier: 00643169143265
• UDI-Public: 00643169143265
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K123153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 6250V-45S
• Device Catalogue Number: 6250V-45S
• Device Lot Number: 0009302705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 102