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

Model Number	0171
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the remote home monitor issued an alert for high out of range pacing impedance measurements for the right ventricular (rv) lead.It was noted that the rv lead has exhibited variable impedance measurements between 1600 ohms and 2000 ohms for more than one year.The patient was brought in for a follow-up where provocative maneuvers were performed and no episodes of noise or sudden changes of the pacing impedance measurements were recorded.During the office visit the rv lead impedance measurement was stable around 1800 ohms.The clinic will continue to perform remote interrogations with ambulatory follow ups every six months.The rv lead remains in service and no adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• 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: 12644129
• Report Number: 2124215-2021-29911
• Device Sequence Number: 1204960
• Product Code: LWS
• UDI-Device Identifier: 00802526373374
• UDI-Public: 00802526373374
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: P910073/S041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• 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: 11/28/2009
• Device Model Number: 0171
• Device Catalogue Number: 0171
• Device Lot Number: 101802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 10/17/2021
• Patient Sequence Number: 1