MAUDE Adverse Event Report: CAMERON HEALTH, INC. SQ-RX PULSE GENERATOR; SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	1010
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the scheduled change out procedure for this subcutaneous implantable cardioverter defibrillator (s-icd), had the associated electrode stuck on its header, with unable to be removed.This device remains in service.At this time, there is no indication a new system or device will be implanted or was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that during the scheduled change out procedure for this subcutaneous implantable cardioverter defibrillator (s-icd), had the associated electrode stuck on its header, with unable to be removed.This device remains in service.At this time, there is no indication a new system or device will be implanted or was implanted.No additional adverse patient effects were reported.Additional information from the field indicates the device remains implanted, with the patient referred to another facility for removal.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that during the scheduled change out procedure for this subcutaneous implantable cardioverter defibrillator (s-icd), had the associated electrode stuck on its header, with unable to be removed.This device remains in service.At this time, there is no indication a new system or device will be implanted or was implanted.No additional adverse patient effects were reported.Additional information from the field indicates the device remains implanted, with the patient referred to another facility for removal.No additional adverse patient effects were reported.At a later date, this s-icd was successfully explanted.A new device was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that during the scheduled change out procedure for this subcutaneous implantable cardioverter defibrillator (s-icd), had the associated electrode stuck on its header, with unable to be removed.This device remains in service.At this time, there is no indication a new system or device will be implanted or was implanted.No additional adverse patient effects were reported.Additional information from the field indicates the device remains implanted, with the patient referred to another facility for removal.No additional adverse patient effects were reported.At a later date, this s-icd was successfully explanted.A new device was implanted.No additional adverse patient effects were reported.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 23897064
• Report Number: 2124215-2025-93152
• Device Sequence Number: 4552526
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: (01)00802526562808(17)150822
• 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: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2026

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: 08/22/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A013851
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 02/02/2026; 02/03/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/15/2026; 02/11/2026; 02/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male