MAUDE Adverse Event Report: CAMERON HEALTH SQ-RX PULSE GENERATOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 1010

Device Problems Inaccurate Synchronization (1609); Under-Sensing (1661)

Patient Problems Syncope (1610); Arrhythmia (1721)

Event Date 11/08/2020

Event Type  Injury  

Event Description

It was reported that this device gave a shock for ventricular tachycardia which accelerated the rhythm to ventricular fibrillation.During the arrhythmia, there was some intermittent undersensing which delayed shock therapy and the patient passed out.The ventricular fibrillation was successfully converted.There were no additional adverse patient effects.The device remains implanted.

Event Description

This supplemental report is being filed to provide additional information regarding device trend inclusion.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited telemetry difficulty issues with no conclusive evidence of a malfunction; please refer to the description for more information regarding the specific circumstances of this event.

• Brand Name: SQ-RX PULSE GENERATOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): CAMERON HEALTH; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11152640
• MDR Text Key: 226232626
• Report Number: 2124215-2020-25991
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/26/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A016224
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 46 YR