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

Model Number	1010
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) and electrode exhibited elevated shock impedance measurements of 155 ohms.Technical services (ts) discussed potential causes and troubleshooting options.Additional information was received that a revision procedure was performed.The device pocket was opened and was repositioned to obtain more contact with the facia.It was reported that the patient had gained a significant amount of weight since implant, and the physician believed that there was a lot of air in the pocket due to the change in body mass index.After the device was repositioned shock impedance measurements were noted to be 185 ohms.The pocket was then flushed and shock impedance measurements decreased to 175 ohms.A 10 joule shock was delivered and shock impedance measurements were noted to be 195 ohms.The physician closed the pocket and was considering referring the patient for potential electrode explant.Additionally, the device was noted to have reached elective replacement indicator (eri).No additional adverse patient effects were reported.This device remains in service.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) and electrode exhibited elevated shock impedance measurements of 155 ohms.It was reported that the patient had gained a significant amount of weight since implant.Technical services (ts) discussed potential causes and troubleshooting options.Additionally, the device was noted to have reached elective replacement indicator (eri).Additional information was received that surgical intervention was undertaken.This device was explanted and replaced.No additional adverse patient effects were reported.The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) and electrode exhibited elevated shock impedance measurements of 155 ohms.It was reported that the patient had gained a significant amount of weight since implant.Technical services (ts) discussed potential causes and troubleshooting options.Additionally, the device was noted to have reached elective replacement indicator (eri).Additional information was received that surgical intervention was undertaken.This device was explanted and replaced.No additional adverse patient effects were reported.The product has been received for analysis.This report will be updated upon completion of analysis.
Additional Manufacturer Narrative
This report is being filed to correct the following fields: b5: describe event or problem d6b: explant date h6: impact codes the returned device was thoroughly inspected and analyzed.Visual inspection 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 (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• 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 ; 6515826168
• MDR Report Key: 14881053
• Report Number: 2124215-2022-23755
• Device Sequence Number: 6282806
• Product Code: LWS
• UDI-Device Identifier: 00802526521300
• UDI-Public: 00802526521300
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2022

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: 03/04/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A010123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 09/26/2022; 10/14/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 09/27/2022; 10/17/2022
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 136 KG