MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information regarding this event is being requested from the field.This report will be updated should additional information be provided.

Event Description

It was reported that a patient had a right atrial (ra) lead that was not fully inserted into the header of a device.No changes have been made at this time and both the ra lead and device remain implanted and in service.No adverse patient effects were reported.

• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9269971
• MDR Text Key: 166030617
• Report Number: 2124215-2019-23383
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 11/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1