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

Model Number 0185

Device Problems Failure to Capture (1081); Appropriate Term/Code Not Available (3191); High Capture Threshold (3266)

Patient Problems Erosion (1750); Unspecified Infection (1930); Heart Failure (2206); Ulcer (2274); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/11/2014

Event Type  Death  

Manufacturer Narrative

This initial report was not submitted previously.As per request by the fda on january 31, 2024, the initial report has been resubmitted in an effort to release follow-up 001 from hold status.

Event Description

It was reported that this right ventricular (rv) lead exhibited loss of capture (loc) and high threshold measurements and was surgically abandoned.Approximately one month later this system was explanted due to infection and erosion.Approximately 2 months later a patient advocate contacted boston scientific to report that this patient had died.According to the patient advocate, this patients condition did not improve following the explant of this rv lead.Subsequently, this patient developed several co morbidities including another infection, blood clots, heart failure and internal bleeding ulcer.This patient was discharged from the hospital to a nursing home and shortly after this patient was transferred to hospice where they expired.

Event Description

It was reported that this right ventricular (rv) lead exhibited loss of capture (loc) and high threshold measurements and was surgically abandoned.Approximately one month later this system was explanted due to infection and erosion.Approximately 2 months later a patient advocate contacted boston scientific to report that this patient had died.According to the patient advocate, this patients condition did not improve following the explant of this rv lead.Subsequently, this patient developed several co morbidities including another infection, blood clots, heart failure and internal bleeding ulcer.This patient was discharged from the hospital to a nursing home and shortly after this patient was transferred to hospice where they expired.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.This follow-up 001 report was originally submitted to the fda on june 13 2014.

Event Description

Boston scientific received information that this product was part of a system revision due to infection and erosion.There were no additional adverse effects reported.The product was explanted.Boston scientific received information in late-may 2014 that this patient advocate contacted boston scientific's latitude patient services to report that this patient had died in early (b)(6) 2014.According to the patient advocate, the patient's condition did not improve following the explant of this recently implanted device and right ventricular (rv) 4-site defibrillation lead.At the time of the explant procedure, two inactive leads that had been surgically capped were also explanted.Subsequently, the patient developed several co-morbidities including another infection, blood clots, heart failure and internal bleeding (ulcer).The patient was discharged from the hospital to a nursing home.Shortly thereafter, the patient was transferred to hospice where the patient died.

• Brand Name: ENDOTAK RELIANCE G
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) 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: 19203751
• MDR Text Key: 341295128
• Report Number: 2124215-2014-06327
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/22/2010
• Device Model Number: 0185
• Device Catalogue Number: 0185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2008
• 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; Death; Life Threatening; Hospitalization
• Patient Age: 90 YR
• Patient Sex: Male