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

Model Number	1010
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an office follow-up, the pulse generator battery status was at end-of-life.The device has been implanted greater than ten years.The patient has been lost to follow-up.The clinic may schedule a replacement procedure.There were no adverse patient effects.The device remains implanted.
Event or Problem Description
This supplemental report is being filed to provide additional information that the product has been explanted and replaced.There were no additional adverse patient effects.It was reported that, during an office follow-up, the pulse generator battery status was at end-of-life.The device has been implanted greater than ten years.The patient has been lost to follow-up.The clinic may schedule a replacement procedure.There were no adverse patient effects.The device remains implanted.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): CAMERON HEALTH, INC.; 905 calle amanecer; suite 300; san clemente CA 92673
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22468433
• Report Number: 2124215-2025-46060
• Device Sequence Number: 4121387
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: (01)00802526562808(17)151103
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/03/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A013796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female