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

Model Number 439888

Device Problems Complete Blockage (1094); Activation, Positioning or Separation Problem (2906)

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

Event Date 06/29/2018

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 an implant procedure, the left ventricular lead lumen was blocked; the physician was unable to insert a guidewire nor stylet more than a few centimeters into the lead.The lead was not used and another was implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

The full lead was returned and analyzed.There was blood on the distal conductor of the lead and it was obstructed.Visual analysis of the lead indicated damage at implant.The analyst noted the test stylet stops insertion at 1.5 cm due to blood obstruction in the lumen of the lead.If information is provided in the future, a supplemental report will be issued.

• 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): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7714630
• MDR Text Key: 114949428
• Report Number: 2649622-2018-12015
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601857
• UDI-Public: 00643169601857
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2020
• Device Model Number: 439888
• Device Catalogue Number: 439888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2018
• 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: 88 YR