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

Model Number	0158
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted due to high pacing threshold.Moreover, the physician suspected that the growth of chronic tissue around the lead caused the increase in threshold.A new lead was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The lead has been received for analysis.Upon completion of the analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted due to high pacing threshold.Moreover, the physician suspected that the growth of chronic tissue around the lead caused the increase in threshold.A new lead was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The lead has been received for analysis.Upon completion of the analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.Upon receipt at our post market quality assurance laboratory.A thorough evaluation of the lead was performed.Analysis did confirm high threshold based on the observation calcification and tissue noted on the lead at the distal coil and tip.It was also noted on the proximal coil and insulation.Furthermore, it was concluded that this was a known inherent risk based on the direct observation of calcium deposits on the tip or electrodes of the returned lead.Calcium deposits have been shown to increase the electrical resistance and thresholds of a lead and are a known risk for implanted cardiac leads.

• Brand Name: ENDOTAK RELIANCE
• 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; 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: 16968174
• Report Number: 2124215-2023-25228
• Device Sequence Number: 5244316
• Product Code: LWS
• UDI-Device Identifier: 00802526531132
• UDI-Public: 00802526531132
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: 04/29/2011
• Device Model Number: 0158
• Device Catalogue Number: 0158
• Device Lot Number: 184163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2009
• 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 Race: Black Or African American