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

Model Number	1010
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) reached elective replacement indicator (eri) back in (b)(6) 2022.Recently, the patient received four inappropriate shocks due to oversensing of mypotoential noise.Additionally, there was long charge times averaging between 20-44 seconds.Troubleshooting was performed and the noise could be re-created.At some point, the patient will be implanted with a cardiac resynchronization therapy defibrillator (crt-d) device.At this time, the system remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) reached elective replacement indicator (eri) back in october 2022.Recently, the patient received four inappropriate shocks due to oversensing of mypotoential noise.Additionally, there was long charge times averaging between 20-44 seconds.Troubleshooting was performed and the noise could be re-created.At some point, the patient will be implanted with a cardiac resynchronization therapy defibrillator (crt-d) device.At this time, the system remains in service.No additional adverse patient effects were reported.This supplemental is being filed as additional information was received that this subcutaneous implantable cardioverter defibrillator (s-icd) was explanted and replaced with a transvenous system.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was inspected and analyzed.Visual examination identified no anomalies.The device was able to be interrogated and a memory download was performed successfully.The device was then exposed to simulated heart load conditions, and the defibrillation and sensing functions were tested.The device operated appropriately, according to its performance specifications with no out of range measurements or interruptions in therapy output.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) reached elective replacement indicator (eri) back in (b)(6) 2022.Recently, the patient received four inappropriate shocks due to oversensing of mypotoential noise.Additionally, there was long charge times averaging between 20-44 seconds.Troubleshooting was performed and the noise could be re-created.At some point, the patient will be implanted with a cardiac resynchronization therapy defibrillator (crt-d) device.At this time, the system remains in service.No additional adverse patient effects were reported.This supplemental is being filed as additional information was received that this subcutaneous implantable cardioverter defibrillator (s-icd) was explanted and replaced with a transvenous system.No additional adverse patient effects were reported.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: IMPLANTABLE DEVICE
• 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: 19092517
• Report Number: 2124215-2024-22198
• Device Sequence Number: 7651712
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• 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: 2024
• 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,Followup
• Report Date (Section B): 11/21/2024

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: 07/16/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A016543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 11/21/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/31/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Other; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male