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

Model Number 9528

Device Problem Circuit Failure (1089)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2014

Event Type  Injury  

Event Description

The implantable loop recorder (ilr) explanted as it was no longer required by the patient.The ilr was returned to the manufacturer and subsequently tested out of specification during manufacturer's analysis.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This report is based solely on device analysis.No information to suggest a device related adverse event or product problem was received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: the device was returned and analyzed.Analysis of the returned device indicated an electrical discontinuity/open in the connector wiring.A no sense condition found at functional test was due to a fractured ribbon wire on connector j2.The fracture was due to fatigue.(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, r; 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: 4676025
• MDR Text Key: 19349451
• Report Number: 3004209178-2015-06449
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2015

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: 07/14/2013
• Device Model Number: 9528
• Device Catalogue Number: 9528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2012
• 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: 00063 YR