MAUDE Adverse Event Report: IPG MFG SWITZERLAND VITATRON DA+ C-SERIES SR; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number C10A3U

Device Problems Device Displays Incorrect Message (2591); Reset Problem (3019)

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

Event Date 05/04/2015

Event Type  Injury  

Event Description

It was reported that the during a device check procedure the implantable pulse generator (ipg) had encountered an error code, and device interrogation was not possible.A power on reset (por) was indicated.Data retrieval was attempted but not possible.The ipg remains in use, and 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.(b)(4).

• Brand Name: VITATRON DA+ C-SERIES SR
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• 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: 4967903
• MDR Text Key: 20804136
• Report Number: 9614453-2015-01966
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Physician
• Type of Report: Initial
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/14/2007
• Device Model Number: C10A3U
• Device Catalogue Number: C10A3U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2015
• Date Device Manufactured: 04/22/2006
• 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