MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS; ELECTRODE, PACEMAKER, PERMANENT

Model Number 5076-45

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2014

Event Type  malfunction  

Event Description

It was reported that during the implant procedure, the stylet was not advancing smoothly, which made the lead manipulation difficult.The lead was positioned in the atrium with some effort but it was eventually discontinued due to its poor pacing and sensing thresholds.The lead was attempted and not used.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.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, analyzed and the outer insulation of the lead was extrinsically breached due to a cut.The outer insulation of the lead was observed to have blood ingression.Visual summary analysis of the lead indicated damage at implant.Stylet insertion test result was passed.Visual analysis found outer insulation breached/ extrinsic and blood ingression.The breach insulation did contribute to the sensing complaint.(b)(4).

• Brand Name: CAPSUREFIX NOVUS
• Type of Device: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; nasaco tech centre, 49 changi; singapore ; SG
• 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: 4161427
• MDR Text Key: 16302996
• Report Number: 3008973940-2014-00374
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930039
• 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: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2015
• Device Model Number: 5076-45
• Device Catalogue Number: 5076-45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2013
• 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