MAUDE Adverse Event Report: IPG MFG SWITZERLAND REVO MRI SURESCAN; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number RVDR01

Device Problems Leak/Splash (1354); Missing Test Results (3267)

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

Event Date 11/25/2014

Event Type  Injury  

Event Description

It was reported that the patient was lost to follow up and the first check done on their implantable pulse generator (ipg) after 30 radiation therapy treatments showed no battery voltage measurement.The device was reprogrammed and the voltage is now available.The device remains in use.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.Products: (b)(4) lead implanted: 2011 (b)(6).(b)(4).

• Brand Name: REVO MRI SURESCAN
• Type of Device: PULSE-GENERATOR, DUAL CHAMBER, 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: 4498354
• MDR Text Key: 21093565
• Report Number: 9614453-2015-00407
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2012
• Device Model Number: RVDR01
• Device Catalogue Number: RVDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 02/10/2015
• Date Device Manufactured: 09/16/2010
• 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: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 00089 YR