MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 429888

Device Problems Device Contamination with Body Fluid (2317); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

It was reported that during the implant of the left ventricular (lv) lead the guidewire was "stuck" in the lead and the physician was unable to remove the guidewire without the lead.After multiple attempts the lead and guidewire were removed together.It was noted the physician was able to remove the wire from the distal end and stated that the end of the wire may have caused the issue because it looked "tied in a knot." there was blood inside the lead.A new lead was implanted successfully.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary- the full lead was returned in segments, analyzed and analysis was performed and no anomalies were found, the outer insulation of the lead was observed to have blood ingression.Visual summary analysis of the lead indicated damage at implant.The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

• Brand Name: ATTAIN PERFORMA
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4314183
• MDR Text Key: 22035862
• Report Number: 2649622-2014-15423
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/03/2016
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2014
• 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: 00077 YR