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

Model Number 439878

Device Problems Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problems Discomfort (2330); Cardiac Perforation (2513)

Event Date 05/20/2015

Event Type  malfunction  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: the full lead was returned and analyzed.Analysis indicated that the distal lv (low voltage) electrode of the lead was covered in body tissue/fibrotic growth.(b)(4).

Event Description

It was reported that during placement of the left ventricular (lv) lead, the physician had difficulty threading the lead all the way out into the branch of the coronary sinus.When lead retraction was attempted, the lead became difficult to pull back and the patient described "discomfort with physician pulling." the possibility of a perforation upon retraction was considered and a heart team was placed on stand-by.The lead was eventually retracted and visible tissue was noted at the tip of the lead, however, no evidence of a perforation was noted via echocardiogram, fluoroscopy or vital signs.An alternative lead was placed.No further patient complications have been reported as a result of this event.

• 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: 4972047
• MDR Text Key: 23677176
• Report Number: 2649622-2015-10301
• 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: company representative,health
• Reporter Occupation: Physician
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2016
• Device Model Number: 439878
• Device Catalogue Number: 439878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2014
• 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 Outcome(s): Life Threatening
• Patient Age: 00061 YR