MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD

Model Number	0665
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Codes	Pneumothorax (2012); Discomfort (2330); Asystole (4442)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient underwent a planned system replacement procedure to upgrade therapy from a pacemaker system to an implantable cardioverter defibrillator (icd) system.After the procedure, the patient was transferred out of the surgical suite and put on a monitor.The nurses monitoring the patient contacted the boston scientific field representative who attended the surgical procedure approximately one hour later indicating the patient was exhibiting pauses in rhythm and some asystole as observed on the monitor.The patient was noted to be pace therapy dependent.The patient also described a sensation of what felt like electricity running down their arm.The patient was provided external pacing therapy and a chest tube was placed due to pneumothorax.When the representative arrived back at the hospital, this newly implanted right ventricular (rv) lead was reprogrammed to maximum pacing output and consistent capture was observed.The physician elected to reposition the new rv lead and connected a pacing system analyzer (psa) to the previous rv lead that had been surgically abandoned in order to provide pacing therapy during the surgical procedure.The new rv lead was surgically repositioned to a slightly different location in the right ventricle and was indicating to be performing well.The rv lead remains in-service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIANCE 4-FRONT
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15365716
• Report Number: 2124215-2022-34456
• Device Sequence Number: 6927614
• Product Code: LWS
• UDI-Device Identifier: 00802526496967
• UDI-Public: 00802526496967
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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: 10/07/2022
• Device Model Number: 0665
• Device Catalogue Number: 0665
• Device Lot Number: 505012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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 Sex: Male