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

Model Number 0157

Device Problems Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Sensing Problem (2917)

Patient Problem Muscle Stimulation (1412)

Event Date 03/01/2018

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) defibrillation lead exhibited shock impedance measurements of less than 20 ohms, pacing impedance measurements of less than 200 ohms, loss of capture, pocket stimulation with pacing, noise, oversensing, inappropriate anti-tachycardia pacing (atp), and inappropriate shocks.A surgical revision was performed, and this lead was surgically abandoned and replaced.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): GUIDANT PUERTO RICO, B.V.; no. 12, road 698; ,; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8250485
• MDR Text Key: 133139337
• Report Number: 2124215-2019-00415
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526531125
• UDI-Public: 00802526531125
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/24/2010
• Device Model Number: 0157
• Device Catalogue Number: 0157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2008
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR