MAUDE Adverse Event Report: MPRI TRANSVENOUS LEAD; ADAPTOR, LEAD, PACEMAKER

Model Number 4016

Device Problems Fracture (1260); High impedance (1291); High Capture Threshold (3266)

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

Event Date 03/18/2015

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) lead exhibited high thresholds and high pacing impedance with a possible fracture.The lead was capped and replaced.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.Concomiant 4512 lead implanted: 1987-(b)(6).(b)(4).

• Brand Name: TRANSVENOUS LEAD
• Type of Device: ADAPTOR, LEAD, PACEMAKER
• 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: 4829392
• MDR Text Key: 5839336
• Report Number: 2649622-2015-04922
• Device Sequence Number: 1
• Product Code: DTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K850968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4016
• Device Catalogue Number: 4016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2015
• 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: ADDR03 IPG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00090 YR