MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	0283
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	Shock (2072)
Date of Event	01/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.As such, physical analysis has not been conducted in our laboratory.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high, out of range shock impedance, rising since november 2021 from 125 ohms to 175 ohms.In 2019, device delivered shock therapy and shock impedance was at 65 ohms.Rv pacing impedance increased from 800 ohms ( at implant) to 1700 ohms.Rv pacing threshold where 0.5ms x 0.5ms (at implant) to 2.7ms x 1.0ms reported today.The physician will continue to monitor the patient over the home monitoring system.The rv lead remains implanted.No adverse patient effects were reported.
Additional Manufacturer Narrative
Device remains implanted.As such, physical analysis has not been conducted in our laboratory.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high, out of range shock impedance, rising since november 2021 from 125 ohms to 175 ohms.In 2019, device delivered shock therapy and shock impedance was at 65 ohms.Rv pacing impedance increased from 800 ohms (at implant) to 1700 ohms.Rv pacing threshold were 0.5ms x 0.5ms (at implant) to 2.7ms x 1.0ms reported today.The physician will continue to monitor the patient over the home monitoring system.A technical service (ts) consultant review device data to provide recommendations for additional testing.Including lead integrity testing with provocation maneuvers/isometrics, x-ray images, pocket manipulation and commanded 1.1j and 41j shocks.Additional information was received that lead integrity testing was completed.A commanded 1.1j shock and 41j shock where completed.Both revealed shock impedance of 120 ohms.Induction testing was completed, and shock impedance was evaluated at 105 ohms through induction testing.The physician will continue monitoring the patient closely.The rv lead remains implanted.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15447203
• Report Number: 2124215-2022-36648
• Device Sequence Number: 4799960
• Product Code: NVY
• UDI-Device Identifier: 00802526431388
• UDI-Public: 00802526431388
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: 09/11/2015
• Device Model Number: 0283
• Device Catalogue Number: 0283
• Device Lot Number: 101432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown