MAUDE Adverse Event Report: MEDTRONIC S.A. (SMO) REVEAL XT; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 9529

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Discomfort (2330)

Event Date 02/12/2014

Event Type  Injury  

Event Description

It was reported that the patient complained the implantable cardiac monitor (icm) was uncomfortable and bothersome.The icm was explanted.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.(b)(4).

Manufacturer Narrative

Product event summary- the device was returned and analyzed.Analysis was performed and no anomalies were found.

• Brand Name: REVEAL XT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC S.A. (SMO); route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3743000
• MDR Text Key: 4222400
• Report Number: 9614453-2014-00742
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2014

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: 01/14/2014
• Device Model Number: 9529
• Device Catalogue Number: 9529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 04/11/2014
• Supplement Dates Manufacturer Received: Not provided; 04/08/2014
• Supplement Dates FDA Received: 06/10/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00058 YR