MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. REVEAL XT; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 9529

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Twiddlers Syndrome (2114)

Event Date 03/24/2015

Event Type  malfunction  

Event Description

It was reported by the patient that their implantable cardiac monitor "flipped over." the patient was advised to discuss the concern with a physician.The icm 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.(b)(4).

• Brand Name: REVEAL XT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• 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: 4831038
• MDR Text Key: 20448062
• Report Number: 3004209178-2015-10842
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2015

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: 05/14/2015
• Device Model Number: 9529
• Device Catalogue Number: 9529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 06/10/2015
• Date Device Manufactured: 10/21/2014
• 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 Age: 00056 YR