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

Model Number	1010
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Delayed Charge Time (2586)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) had reached the elective replacement indicator (eri).Long charge (lc) error was also found, which is indicative of charge time exceeding limitations.It was recommended that the product be explanted and replaced.At this time, this s-icd system remains in service and no adverse patient effects were reported.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) had reached the elective replacement indicator (eri).A long charge (lc) error was also found, indicating that the charge time exceeded the limit.It was recommended that the device be explanted and replaced.Subsequently, a revision procedure was performed and the s-icd was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) had reached the elective replacement indicator (eri).A long charge (lc) error was also found, indicating that the charge time exceeded the limit.It was recommended that the device be explanted and replaced.Subsequently, a revision procedure was performed and the s-icd was explanted and replaced.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.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: 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: 20081590
• Report Number: 2124215-2024-53636
• Device Sequence Number: 18042029
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2025

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: 09/26/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A017191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 05/30/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/25/2024; 05/30/2025
• 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; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male