MAUDE Adverse Event Report: MEDTRONIC, INC. PACEART OPTIMA; ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT

Model Number POS12D15

Device Problem Communication or Transmission Problem (2896)

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

Event Date 02/26/2016

Event Type  malfunction  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that the patient management database application was showing right ventricular (rv) lead values on a single chamber device with a single lead implanted in the atrium.The caller was advised this may be a data mapping issue and has been escalated to the development team.No patient complications have been reported as a result of this event.On (b)(6) 2016, 07:03:01: it was later reported that the device manufacturer was contacted to fix how they are creating the file.Until the issue is resolved the data in the patient management database application will need to be manually fixed.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACEART OPTIMA
• Type of Device: ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5559417
• MDR Text Key: 42790812
• Report Number: 2182208-2016-01000
• Device Sequence Number: 1
• Product Code: KRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: POS12D15
• Device Catalogue Number: POS12D15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1