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

Model Number 459888

Device Problems Pacing Inadequately (1442); High Capture Threshold (3266)

Patient Problem Muscle Stimulation (1412)

Event Date 04/08/2015

Event Type  malfunction  

Event Description

It was reported that during the implant procedure the physician was unable to get acceptable left ventricular (lv) lead thresholds without diaphragm stimulation.The lead was removed and different lead was utilized.Also during the same procedure the physician noticed the valve on the delivery catheter had some backflow of blood when introduced to the patient vasculature.The physician chose to continue use of the device for the remainder of the procedure.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed.Analysis was performed and no anomalies were found.

Manufacturer Narrative

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): 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: 4833379
• MDR Text Key: 5908285
• Report Number: 2649622-2015-07127
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/11/2017
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 06/10/2015
• Supplement Dates Manufacturer Received: Not provided; 06/17/2015
• Supplement Dates FDA Received: 08/05/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• 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: 00067 YR