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

Model Number POS12D15

Device Problems Communication or Transmission Problem (2896); Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 04/05/2016

Event Type  malfunction  

Event Description

It was reported that data imported into the patient management database application from a competitor monitor was not correct.The customer observations were reported to development for escalation.There was no patient involvement.

• 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: 5712858
• MDR Text Key: 47149150
• Report Number: 2182208-2016-01550
• Device Sequence Number: 1
• Product Code: KRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• 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: 04/05/2016
• 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