MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE LEAD

Model Number 0181

Device Problem High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2020

Event Type  malfunction  

Event Description

It was reported that the communicator displayed the red call doctor icon.The patient called boston scientific technical services (ts) who helped them to send the transmission and instructed them to contact their physician.High out-of-range pace impedances of greater than 3000 ohms were detected on the right ventricular lead.The device and leads remain in service.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• Type of Device: 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; RQ 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11237351
• MDR Text Key: 228909258
• Report Number: 2124215-2020-29188
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526531156
• UDI-Public: 00802526531156
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/11/2020
• Device Model Number: 0181
• Device Catalogue Number: 0181
• Device Lot Number: 337294
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR