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

Model Number 0185

Device Problems Unexpected Therapeutic Results (1631); Material Integrity Problem (2978)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 01/08/2024

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead had a bad shocking coil and exhibited high defibrillation thresholds.It was noted that the patient required a defibrillation threshold (dft) test every 6 months to make sure there was effective shock therapy.It was noted that only the 41 joule (j) shock was successful at the last dft.The physician decided to explant and replace the lead.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE G
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18564640
• MDR Text Key: 333491081
• Report Number: 2124215-2024-03344
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/23/2008
• Device Model Number: 0185
• Device Catalogue Number: 0185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Male