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 Nerve Damage (1979); Tingling (2171)

Event Date 05/27/2014

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency room complaining of pain, tingling up the neck and shoulders and stress headaches.The symptoms were noted to be due to the implantable loop recorder (ilr) trying to push through the skin which was causing nerve damage.The patient was treated with medications for the pain.All heart tests were normal so the device was scheduled for explant.No further 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 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: 3991432
• MDR Text Key: 4955244
• Report Number: 3004209178-2014-14289
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2014

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?: No
• 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?: No
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 08/08/2014
• Date Device Manufactured: 11/20/2013
• 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: 00049 YR