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

Model Number 0296

Device Problem High impedance (1291)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported that during a routine follow up, a manual shock impedance test was performed, and this right ventricular (rv) lead exhibited high out of range (oor) measurements greater than 200 ohms.Boston scientific technical services (ts) reviewed data from the device and found that there are currently no oor shock impedance measurements.And explained that the impedance trend data shows the daily lead test measurements and does not display manual test measurements made in-clinic.The rv lead trend data for the last 12months shows in-range intrinsic amplitude, pace, sense and shock impedance measurements.Ts also indicated that provocative maneuvers could be performed while making shock impedance measurements to evaluate for oor impedance values.It was discussed that an intermittent high shock impedance greater than 200 ohms could potentially point towards lead impairment, including lead fracture, so a troubleshooting guide was provided in order to further evaluate this observation.A follow up was scheduled to perform x-ray imaging and provocation tests.The lead remains in service and no adverse patient effects have been 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): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18903622
• MDR Text Key: 337657928
• Report Number: 2124215-2024-15522
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2012
• Device Model Number: 0296
• Device Catalogue Number: 0296
• Device Lot Number: 025412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2010
• 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