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

Model Number 9528

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Death (1802); Unspecified Infection (1930)

Event Date 10/04/2013

Event Type  Death  

Event Description

A journal article was reviewed which contained information regarding this implantable loop recorder (ilr).The article included the following failure modes: deaths, erosion, infection, and device "malfunction." information obtained through follow up indicated that this patient had expired.The cause of death was noted to be by cardiogenic shock.Of note, there were no arrhythmias.No further information was provided.

Manufacturer Narrative

This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.If additional relevant information is received, a supplemental report will be submitted.There is no information given as to the exact date of death for the patient; therefore, the date of death included in this report is purely an estimate.Patient information is limited due to confidentiality concerns.Referenced article: implantable loop recorder allows an etiologic diagnosis in one-third of patients - results of the spanish reveal registry.Circ.J.2013;77(10):2535-2541.(b)(4).

• Brand Name: REVEAL DX
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park; road 31 km. 24, hm 4; 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: 3620706
• MDR Text Key: 20265661
• Report Number: 3004209178-2014-02731
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2014

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: 08/28/2008
• Device Model Number: 9528
• Device Catalogue Number: 9528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/10/2014
• Date Device Manufactured: 09/12/2007
• 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): Death