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

Device Problems Failure to Capture (1081); Over-Sensing (1438); Under-Sensing (1661); High Capture Threshold (3266)

Patient Problem Syncope/Fainting (4411)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this patient with this newly implanted unknown device system presented to the emergency department unresponsive initially with a history of having unknown device issues three days prior.This patient was discharged and then today was unresponsive in their bedroom.Upon review, this patient had runs of ventricular tachycardia (vt) on the external monitor and chest compressions were almost initiated.Some episodes had sustained rates above and below the detection zones and did not meet the criteria for therapies.Left ventricular (lv) lead threshold measurements were unable to measured and capture was unable to be confirmed on the presenting electrogram (egm).High right ventricular (rv) lead thresholds measurements were observed from 2023.Intermittent atrial and ventricular undersensed beats were observed along with rv oversensing.It is unknown if this device system remains in service.No additional 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 (Section G): 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: 19117024
• MDR Text Key: 340287876
• Report Number: 2124215-2024-22877
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization