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

Model Number 0175

Device Problems Fracture (1260); High impedance (1291); High Capture Threshold (3266)

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

Event Date 02/14/2014

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead and implantable cardioverter defibrillator (icd) displayed pacing impedance measurements of greater than 2000 ohms.Of note, the lead had displayed pacing impedances in the 1900 ohm range with the previous device.Additionally, an increase in pacing thresholds to 7 volts was reported.There was no noise present.Which was believed to be caused by a lead fracture.Subsequently, a revision procedure was performed and the icd system was replaced.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: 17035326
• MDR Text Key: 316287559
• Report Number: 2124215-2023-27711
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526373732
• UDI-Public: 00802526373732
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2007
• Device Model Number: 0175
• Device Catalogue Number: 0175
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2005
• 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; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male