MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	0650
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient's remote communicator displayed a red call doctor icon.Subsequently, troubleshooting was performed, and the communicator was power cycled, and a successful patient-initiated interrogation was sent.The patient was referred to contact their clinic regarding the red call doctor icon.Additional information was received that this implantable cardioverter defibrillator (icd) exhibited a high out of range right ventricular (rv) lead pacing impedance measurement, measuring greater than 2000 ohms.Subsequently, this patient was brought into clinic for further troubleshooting.The physician opted to turn tachy therapies off for this patient at that time.At this time, evidence suggests the device system remains in-service.No adverse patient effects were reported.

• Brand Name: RELIANCE 4-FRONT
• 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: 12620379
• Report Number: 2124215-2021-26065
• Device Sequence Number: 19701282
• Product Code: LWS
• UDI-Device Identifier: 00802526592843
• UDI-Public: 00802526592843
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S145
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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: 09/18/2021
• Device Model Number: 0650
• Device Catalogue Number: 0650
• Device Lot Number: 101416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR