MAUDE Adverse Event Report: EOC HEERLEN DISTRIBUTION CTR ATTAIN STABILITY; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 20066

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 09/11/2014

Event Type  malfunction  

Event Description

It was reported that during an implant attempt, inside blood penetration during lead handling occurred after using guidewire.The lead was removed and replaced with a new lead.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This model number is not approved for distribution in the u.S., however, it is similar to a device marketed in the u.S.The event occurred outside the us and is being reported due to an alleged malfunction.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Product event summary: the full lead was returned and analyzed.Analysis was performed and no anomalies were found.There was blood on the distal conductor of the lead and it was not obstructed.(b)(4).

• Brand Name: ATTAIN STABILITY
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): EOC HEERLEN DISTRIBUTION CTR; earl bakkenstraat 10; heerlen 6422 PJ; NL 6422 PJ
• 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: 4311234
• MDR Text Key: 22058799
• Report Number: 3002807561-2014-00018
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2016
• Device Model Number: 20066
• Device Catalogue Number: 20066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2014
• 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