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

Model Number 0273

Device Problems Mechanical Problem (1384); Pocket Stimulation (1463)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the helix difficulty allegation was confirmed based on inner insulation damage and conductor coil offset/deformed on several locations along the lead body.On some occasions, the friction force that results from contact between the lead and a constricted area is enough to cause the insulation to bunch up.The significant bunched of the insulation had caused the conductor coils to become offset, which results in helix mechanism difficulty and the stylet insertion may be impeded.The lead passed all electrical performance and inner insulation integrity testing which indicate that the lead conductors were intact.

Event Description

It was reported that the patient was experiencing muscle/ pocket stimulation during implant procedure of this lead.In addition, the helix was having trouble extending due to multiple attempts of repositioning.It was then opted to use another lead.The lead was never in service.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11767019
• MDR Text Key: 248801745
• Report Number: 2124215-2021-11732
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526601811
• UDI-Public: 00802526601811
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Model Number: 0273
• Device Catalogue Number: 0273
• Device Lot Number: 107582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2020
• 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 Age: 75 YR