MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SUBCUTANEOUS PATCH ELECTRODE; Implantable cardioverter defibrillator (non-CRT)

Model Number 497-10-50

Device Problems Pocket Stimulation (1463); Defective Device (2588)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this right atrial (ra) lead suspected to have insulation damage.The physician found pocket stimulation and checked for insulation breaks.This lead was repaired and pocket stimulation was better.This lead remains in service.No additional adverse patient effects were reported.

• Brand Name: SUBCUTANEOUS PATCH ELECTRODE
• Type of Device: Implantable cardioverter defibrillator (non-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17568627
• MDR Text Key: 321401448
• Report Number: 2124215-2023-44330
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 497-10-50
• Device Catalogue Number: 497-10-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male