MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO REVEAL XT; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 9529

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Chest Tightness/Pressure (2463)

Event Date 05/24/2013

Event Type  Injury  

Event Description

It was reported by the patient that they "hurt ever since the device was implanted" and "it's too much pressure".The physician is currently monitoring the patient.The device remains in use.No patient complications have been reported as a result of this event.On (b)(6)2014, it was further reported that the patient was diagnosed with paroxysmal atrial fibrillation (af).The physician opted to remove the device.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: the device was returned and analyzed.Analysis was performed and no anomalies were found.(b)(4).

• Brand Name: REVEAL XT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• 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: 3989137
• MDR Text Key: 4889602
• Report Number: 3004209178-2014-14145
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2014
• Device Model Number: 9529
• Device Catalogue Number: 9529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2013
• 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: 00081 YR