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	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device battery had reached end of life back in 2022.The device had been implanted greater than eight years.It was decided to leave the pulse generator implanted.Recently, the patient wanted the system explanted.The entire system was explanted successfully.The condition of the patient had improved so no replacement was done.There were no additional adverse patient effects.

• 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; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50324073
• Report Number: 2124215-2026-44575
• Device Sequence Number: 9982959
• Product Code: LWS
• UDI-Device Identifier: 00802526521300
• UDI-Public: (01)00802526521300(17)150305
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2026

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: 03/05/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A009086
• 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: Not provided
• Initial Report FDA Received Date: 08/19/2026
• 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: 39 YR
• Patient Sex: Male