MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	0636
Medical Device Problem Codes	Defective Device (2588); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular (rv) lead appeared to be in the right atrial (ra) based on x-ray.Further, this lead was explanted due to loose connection and dislodgement.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead appeared to be in the right atrial (ra) based on x-ray.Further, this lead was explanted due to loose connection and dislodgement.No additional adverse patient effects were reported.Additional information indicated that there was no header connection issue.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.The allegation dislodgement was not confirmed as evidence from the field and product analysis were insufficient to verify allegation.Moreover, the no problem detected was based on the analysis of the returned product.There were no found evidence of lead defect, malfunction or damage outside the bounds of normal medical use.This supplemental is being filed to correct the h6:device codes.

• Brand Name: RELIANCE 4-FRONT
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12218741
• Report Number: 2124215-2021-20599
• Device Sequence Number: 14576689
• Product Code: LWS
• UDI-Device Identifier: 00802526496868
• UDI-Public: 00802526496868
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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: 03/23/2022
• Device Model Number: 0636
• Device Catalogue Number: 0636
• Device Lot Number: 504073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR