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

Model Number 429688

Device Problems Intermittent Capture (1080); Capturing Problem (2891); High Capture Threshold (3266)

Patient Problems Syncope (1610); Ventricular Tachycardia (2132)

Event Date 05/18/2013

Event Type  malfunction  

Event Description

It was reported that the left ventricular (lv) lead had a rise in threshold and is chronically high.The lead also has intermittent capture.The lead remains in use.The patient is enrolled in the (b)(6) study.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.Products: (b)(4) icd, implanted: 2013 (b)(6); 6947 lead, 2012 (b)(6); 4574 lead, 2011 (b)(6).(b)(4).

• Brand Name: ATTAIN ABILITY PLUS
• 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 DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3858794
• MDR Text Key: 4684307
• Report Number: 2649622-2014-06284
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2014

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: 10/29/2014
• Device Model Number: 429688
• Device Catalogue Number: 429688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 06/10/2014
• Date Device Manufactured: 01/17/2013
• 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
• Treatment: 4074 LEAD
• Patient Age: 00061 YR