MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 185

Device Problem Pocket Stimulation (1463)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924); Pocket Erosion (2013)

Event Type  Injury  

Event Description

Explant of device and lead due to pocket infection.Gram negative rods identified on wound culture (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ENDOTAK RELIANCE G
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17527842
• MDR Text Key: 321054955
• Report Number: MW5134773
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 185
• Patient Sequence Number: 1