MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SQ-RX PULSE GENERATOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	1010
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this device exhibited fault codes for long charge times.The device has been implanted greater than seven years and has 5% battery remaining.A review of device downloaded memory was done by technical services and the long charge times were confirmed.The device remains implanted, however technical services recommended explant.There were no adverse patient effects.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the device was examined.Visual inspection noted no damage.The device was then exposed to simulated heart load conditions, and the defibrillation functions were tested.The device operated appropriately, according to its performance specifications with no interruptions in therapy output or programmer communication at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Laboratory analysis did not identify any characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
This supplemental report is being filed to provide additional information regarding product analysis.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 this device exhibited fault codes for long charge times.The device has been implanted greater than seven years and has 5% battery remaining.A review of device downloaded memory was done by technical services and the long charge times were confirmed.The device remains implanted, however technical services recommended explant.There were no adverse patient effects.
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 this device exhibited fault codes for long charge times.The device has been implanted greater than seven years and has 5% battery remaining.A review of device downloaded memory was done by technical services and the long charge times were confirmed.The device remains implanted, however technical services recommended explant.There were no adverse patient effects.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• 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: 16536594
• Report Number: 2124215-2023-11856
• Device Sequence Number: 17644206
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2024

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: 10/21/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A014097
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 03/30/2023; 01/17/2024
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/12/2023; 01/17/2024
• 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: Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female