MAUDE Adverse Event Report: IPG MFG SWITZERLAND REVEAL XT; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 9529

Device Problems Over-Sensing (1438); Under-Sensing (1661)

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

Event Date 10/09/2016

Event Type  malfunction  

Event Description

It was reported that intermittent undersensing and oversensing was observed on the device report.The device is still in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: REVEAL XT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6164516
• MDR Text Key: 62318053
• Report Number: 9614453-2016-07587
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2016

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: 11/14/2014
• Device Model Number: 9529
• Device Catalogue Number: 9529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: 10/09/2016
• Supplement Dates FDA Received: 09/26/2017
• Date Device Manufactured: 11/21/2013
• 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