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

Model Number 0282

Device Problem High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2024

Event Type  malfunction  

Event Description

It was reported that the device was beeping, and the patient was going to be seen as a result for a follow up.Provocation testing and x-ray was suggested to be done as this right ventricular (rv) lead had been implanted for seventeen years.Technical services (ts) reviewed the data and noted that over the past year the average shock impedance measurements were greater then 160 ohms and increasing to 180 ohms.The rv pace thresholds had remained constant and review of the available electrograms (egm) was clean of artifacts with no recent therapy.Ts noted that observations of gradually rising shock impedance can be attributed to patient related factors resulting in calcification/mineralization buildup on the coil.Ts wanted to assure the effectiveness of shock delivery and noted that when the average shock impedance for a single coil lead is above 150 ohms, technical service recommends consideration be given to a commanded 1.1j r-wave sync shock.If the value after the commanded shock is less then 120 ohms regular follow up was recommended, and if the value is greater then 120 ohms to check if 145 ohms is reached further investigation would be warranted.The field representative noted that the superior vena cava coil was turned off and the values had decreased to less than 145 ohms.At this time the rv lead remains implanted.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• Type of Device: 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: 18951491
• MDR Text Key: 338261619
• Report Number: 2124215-2024-17203
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): Y
• Reporter Country Code: NZ
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2013
• Device Model Number: 0282
• Device Catalogue Number: 0282
• Device Lot Number: 101039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1