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

Model Number 0135

Device Problem Material Integrity Problem (2978)

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

Event Date 03/08/2023

Event Type  Injury  

Manufacturer Narrative

At this time, no further information is available.Should additional information become available this report will be updated.

Event Description

It was reported that this right ventricular (rv) lead exhibited a non-specific issue on the lead body.This was found during a device replacement procedure.The physician decided to use a medical adhesive included in the lead repair kit and a suture sleeve over the area.Technical services (ts) recommended to perform lead monitoring through a pacing system analyzer (psa).The physician performed lead measurements with the psa and all were reported to be in range.This lead remains in service.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK ENDURANCE
• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16636770
• MDR Text Key: 312227012
• Report Number: 2124215-2023-14729
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P910073/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2002
• Device Model Number: 0135
• Device Catalogue Number: 0135
• Device Lot Number: 302108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization