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

Model Number	0182
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient's implantable cardioverter defibrillator started emitting beeping tones.Technical services (ts) reviewed this device data and noticed high out-of-range (oor) shock impedance of 125 ohms.The beeping was confirmed to have been triggered by the impedance measurement.The shock impedance trending appears to be slightly elevated over the last year.As 125 ohms is not indicative of a lead fracture, ts recommended to bring the patient into clinic to turn beeping off, evaluate the shock lead, increase the oor alert to 150 ohms and continue monitoring the patient.If impedance exceeds 150 ohms a commanded shock should be considered.Further information was received indicating that no commanded shocks were performed, and the patient will continue to be monitored.This lead remains in service and no adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12644221
• Report Number: 2124215-2021-30748
• Device Sequence Number: 16497992
• Product Code: LWS
• UDI-Device Identifier: 00802526531163
• UDI-Public: 00802526531163
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2021

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: 01/23/2014
• Device Model Number: 0182
• Device Catalogue Number: 0182
• Device Lot Number: 300761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/17/2021
• Patient Sequence Number: 1
• Patient Age: 32 YR