MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SQ-RX PULSE GENERATOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 1010

Device Problems Difficult to Remove (1528); Human-Device Interface Problem (2949)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

Representatives from our quality assurance, manufacturing, and design engineering groups are actively investigating this behavior.Our ongoing investigation efforts are currently focused on understanding the root cause to mitigate the potential for setscrew issues when disconnecting the electrode from these s-icds.Information gained through these efforts will be utilized to implement appropriate preventive action(s), as necessary.

Event Description

It was reported that there was difficulty to loosen the set screw to replace the device.Technical services discussed troubleshooting.The product was successfully explant.There were no adverse events.

• Brand Name: SQ-RX PULSE GENERATOR
• 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 CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16539404
• MDR Text Key: 311255892
• Report Number: 2124215-2023-11987
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526521300
• UDI-Public: 00802526521300
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/12/2014
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A007330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Date Manufacturer Received: 02/17/2023
• 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 Age: 53 YR
• Patient Sex: Female