MAUDE Adverse Event Report: MPRI CAPSURE SENSE; ELECTRODE, PACEMAKER, PERMANENT

Model Number 407458

Device Problem Difficult to Advance (2920)

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

Event Date 04/03/2015

Event Type  malfunction  

Event Description

It was reported that the guidewire could not get into the right ventricular (rv) lead while attempting to adjust the rv lead position during the implant procedure.The rv lead was explanted and replaced.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.(b)(4).

Manufacturer Narrative

Product event summary: the full lead was returned, analyzed and no anomalies were found.It was noted the stylet/guidewire was kinked/buckled and there was blood on the distal conductor of the lead and it was not obstructed.Visual summary analysis of the lead indicated damage at implant and stretching.The analyst commented that a 14-58 mdt stylet was returned with lead and was bent/kinked in various locations.A fresh 14-58 was used and passed with some resistance felt and there was blood is visible in connector.It was noted blood is the likely cause of resistance.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSURE SENSE
• Type of Device: ELECTRODE, PACEMAKER, PERMANENT
• 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: 4833047
• MDR Text Key: 5932448
• Report Number: 2649622-2015-07300
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P830061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2016
• Device Model Number: 407458
• Device Catalogue Number: 407458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2014
• 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 Age: 00066 YR