MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC; ADVANTIO K063

Model Number K063

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 08/09/2015

Event Type  Injury  

Event Description

"mv chop" observed on remote pacemaker transmission on one occasion.It has not been observed again.Reporting now as more events have been noted in pacemaker patients within the hospital system.Pacemaker remains implanted, no ill effects to patient known at this point.Programming per recommendations is planned.

• Brand Name: BOSTON SCIENTIFIC
• Type of Device: ADVANTIO K063
• Manufacturer (Section D): BOSTON SCIENTIFIC; st. paul MN
• MDR Report Key: 7154568
• MDR Text Key: 96177095
• Report Number: MW5074305
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: K063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR