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

Model Number	0262
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient observed a flashing red call doctor (rcd) icon on their remote monitoring communicator.A forced call was completed on the communicator, device data was successfully transmitted, and the flashing rcd vanished.Boston scientific technical services (ts) referred the patient to their clinic.A subsequent review of the remote monitoring data indicated this right ventricular (rv) lead exhibited an alert for a high out of range pace impedance measurement of 2002 ohms, which triggered the rcd icon.The rv pace impedance trend graph shows at least one previous high out of range measurement followed by a decrease into the 1200 ohm range, which is within normal limits, and a recent gradual increase over approximately the past two months.The lead remains in-service.No patient symptoms or adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE G
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12113331
• Report Number: 2124215-2021-15506
• Device Sequence Number: 11869491
• Product Code: LWS
• UDI-Device Identifier: 00802526601828
• UDI-Public: 00802526601828
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/21/2022
• Device Model Number: 0262
• Device Catalogue Number: 0262
• Device Lot Number: 100263
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 07/03/2021
• Patient Sequence Number: 1
• Patient Age: 68 YR