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

Model Number 0272

Device Problems Failure to Capture (1081); Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 01/24/2024

Event Type  Injury  

Event Description

It was reported that, this right ventricular (rv) lead dislodged and as a result the patient received ten inappropriate shocks.Due to difficulty anatomy the rv lead was initially difficult to placed.The plan is to let the current wound heal, explant the transvenous system and implant a subcutaneous implantable cardioverter defibrillator (s-icd) system.The tachy therapy was turned off due to the inappropriate shocks.This rv lead remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that, this right ventricular (rv) lead dislodged and as a result the patient received ten inappropriate shocks.Due to difficulty anatomy the rv lead was initially difficult to placed.The plan is to let the current wound heal, explant the transvenous system and implant a subcutaneous implantable cardioverter defibrillator (s-icd) system.The tachy therapy was turned off due to the inappropriate shocks, low sensing and no capture.Additional information was received which indicated that, the physician decided to implant a subcutaneous implantable cardioverter defibrillator (s-icd), explant this rv lead and remained the icd implanted and act as an aair pacemaker.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): 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: 18647492
• MDR Text Key: 334612015
• Report Number: 2124215-2024-06409
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526601804
• UDI-Public: 00802526601804
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0272
• Device Catalogue Number: 0272
• Device Lot Number: 117185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• 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: 75 YR
• Patient Sex: Male