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

Device Problems Connection Problem (2900); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  malfunction  

Event Description

It was reported that during routine follow up, high capture thresholds were noted on the right atrial (ra) lead.It was decided by the physician to perform an x-ray and it was observed that the ra lead is not well connected with this implantable device.Subsequently, the physician decided to leave the device system in service due to the risk of infection and to reprogram the device to leave the atrial lead out of the configuration.Reportedly, the patient is not pacemaker dependent.There were no patient adverse effects.Additional information provided indicates that the pin connector of the ra lead was not well connected with the device.The device model/serial is not available as per information from the field representative, however, it is confirmed that the device is a boston scientific product.

• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12701625
• MDR Text Key: 278530890
• Report Number: 2124215-2021-32048
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/26/2021

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: 09/30/2021
• Initial Date FDA Received: 10/26/2021
• 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