MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VITATRON C10 S SERIES; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number C10A3U

Device Problems Electromagnetic Interference (1194); Failure to Interrogate (1332); Over-Sensing (1438)

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

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device memory of the implantable pulse generator (ipg) was damaged three months post radiotherapy session.Consequently, the telemetry was unsuccessful and communication with the programmer failed.The ipg remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: VITATRON C10 S SERIES
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8695114
• MDR Text Key: 147869722
• Report Number: 9614453-2019-01931
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2007
• Device Model Number: C10A3U
• Device Catalogue Number: C10A3U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 11/26/2019; 04/13/2020
• Supplement Dates FDA Received: 11/27/2019; 04/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2006
• 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