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

Model Number 6250V-MB2

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant attempt, the left ventricular (lv) lead insulation was damaged when the guide catheter pierced through side of the lead near the distal electrode.There was no pacing in all polarities even at high voltage which seemed unusual.Upon extracting, the lead and catheter would not move.The implanter managed to extract the lead after five minutes of appropriate manipulation.A new lead was implanted instead.No patient complications have been reported as a result of this event.

• 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 Key: 11709015
• MDR Text Key: 250267773
• Report Number: 9612164-2021-01617
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6250V-MB2
• Device Catalogue Number: 6250V-MB2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR