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

Model Number	0182
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Fracture (1260); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Low impedance (2285)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lead was inadvertently discarded following the procedure.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that this implantable defibrillation lead exhibited oversensed noise resulting in inappropriate anti-tachycardia pacing (atp) and inappropriate shocks.It was also noted that the impedance and sensing measurements had decreased.There was a concern the lead had fractured.Tachy therapy was programmed off and the patient was placed on an external defibrillator prior to a revision procedure.Subsequently, the lead was explanted and successfully replaced.No additional 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: 10013526
• Report Number: 2124215-2020-09478
• Device Sequence Number: 2208611
• Product Code: LWS
• UDI-Device Identifier: 00802526531163
• UDI-Public: 00802526531163
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/04/2013
• Device Model Number: 0182
• Device Catalogue Number: 0182
• Device Lot Number: 300628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2020
• Initial Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR