MAUDE Adverse Event Report: VITATRON MEDICAL B.V. SELECTION; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number SL9000U

Device Problem Reset Problem (3019)

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

Event Date 02/03/2015

Event Type  Injury  

Event Description

It was reported that the implantable pulse generator (ipg) was in reset mode after a cardioversion.The device was reprogrammed and remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This model number is not approved for distribution in the united states; however, it is same/similar to a device marketed in the u.S.This event occurred outside the us and patient information is not generally available due to confidentiality concerns.All information provided is included in this report.(b)(4).

• Brand Name: SELECTION
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): VITATRON MEDICAL B.V.; p.o. box 76, 6950; dieren,nl ; NL
• 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: 4678353
• MDR Text Key: 22061634
• Report Number: 6000095-2015-00003
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P990001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2005
• Device Model Number: SL9000U
• Device Catalogue Number: SL9000U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Date Device Manufactured: 03/16/2004
• 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): Required Intervention